Drug Safety Resume Sample
Sienna Gerlach
2350 Vallie Trail,
Dallas,
TX
+1 (555) 752 1776
Work Experience
Senior Drug Safety Physician
03/2018
-
PRESENT
Houston, TX
- Ensure that given timelines are met according to project and regulatory timelines
- Process and evaluate AE reports according to the customer’s standard operating procedures (SOPs): write/review the narrative, perform seriousness rating and causality assessment
- Perform medical review of individual cases or safety reports
- Perform ICSR signal/trend detection
- Perform Aggregate line listing signal/trend detection
- Review SAE and AE coding to ensure medical accuracy with the verbatim reported term
- Ensures medical and scientific input in study protocols and reports
- Write/participate in writing safety reports (RMPs, PSURs, ARs, SBRs, Issue workups, annual reports…)
Drug Safety Physician
02/2014
-
01/2018
Philadelphia, PA
- The preparation of a case, from receipt to initial assignment in the database
- The completion of case information in the database, culminating in Quality Review to ensure accuracy and completeness
- Completion of all assigned training on company and GMSO procedural documents relating to case receipt/processing
- Completion of training for relevant PV Agreements for assigned products
- Provide assistance in supporting revision/creation of case receipt procedural documents
- Participate in preparation for audits and inspections; assist in supporting inspections and audits
- Provide support for local or global project teams
Internship, Medical Information & Drug Safety
12/2007
-
11/2013
Dallas, TX
- Ensure effective co-ordination of trial safety logistics across the EMEA/APAC, drawing input from relevant lead product safety physicians and trials safety managers
- Five years’ experience in Drug Safety
- Assists with maintaining the SharePoint website for Safety and Pharmacovigilance
- Perform aggregate safety data review, safety surveillance activities to review for potential safety signals and provide guidance on the regulatory status for expedited reporting and/or signal detection
- Support internal and external customers related to the evaluation of issues and adverse events related to licensed products safety and efficacy. Share medical/clinical expertise with counterparts in other functional areas such as quality assurance, regulatory affairs, marketing, manufacturing, and legal globally
- Work with the global labeling team to accurately portray the safety profile of assigned drugs
- Serve as a medical liaison between Global Patient Safety and other Global Business Unit medical team members
- Maintain knowledge of global regulatory authority regulations (especially FDA and EMA)
- Contribute to the training, leadership and continuing education for all departmental staff
Education
University of Central Florida - Ocala Campus
2003 - 2007
Science's Degree in Nursing
Professional Skills
- Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective cross‑ department communication
- Excellent verbal and written communication skills in relating to colleagues and associates both inside and outside the organization
- Work effectively with multi-disciplinary teams. Use teamwork skills to achieve goals, solve problems, and manage conflict required
- Strong computer skills in drug safety applications and other office applications required
- Applies critical thinking skills to solve problems by generating, evaluating, and implementing solutions required
- Proven experience in customer handling and relationship
- Resourcefulness and personal organization skills required
How to write Drug Safety Resume
Drug Safety role is responsible for medical, organizational, computer, interpersonal, database, events, leadership, excel, english, windows.
To write great resume for drug safety job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Drug Safety Resume
The section contact information is important in your drug safety resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Drug Safety Resume
The section work experience is an essential part of your drug safety resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous drug safety responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular drug safety position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Drug Safety resume experience can include:
- Conduct medical review of individual case safety reports (ICSR) within workflow timelines and per ICH-GCP guidelines, regulatory requirements and company’s SOPs
- Excellent organizational, problem-solving, and interpersonal skills and the ability to meet timelines
- Proficient in word processing skills in a Windows environment and excellent attention to detail
- Strong analytical and problem-solving skills with superb attention to detail
- Excellent computer skills (Microsoft Word, Excel, Outlook, Access) and advanced safety database proficiency
- Experience working with drug safety department forecasting and budgeting with a strong business sense required
Education on a Drug Safety Resume
Make sure to make education a priority on your drug safety resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your drug safety experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Drug Safety Resume
When listing skills on your drug safety resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical drug safety skills:
- Excellent communication skills, organizational skills, time management skills, fast learner, ability to multi-task, detail oriented and problem solver
- Strong organizational skills, including the ability to prioritize and multi task
- Good man management experience with the skill to lead, develop and motivate a global team
- Strong line management and project management skills
- Demonstrates leadership skills - both direct and via influence
- Excellent German and English language skills, both written and verbal including medical / pharmaceutical terminology
List of Typical Experience For a Drug Safety Resume
1
Experience For Senior Drug Safety Physician Resume
- A quality driven individual with strong attention to detail and accuracy is required. Strong organizational skills, and ability to adapt to change
- Demonstrates a good level of competency in verbal and written communication, including Microsoft Excel, Office, Word, and PowerPoint
- Demonstrate knowledge and experience of global post marketing and clinical trial regulations
- At least three years' experience in multiple areas of Drug Safety management with project lead responsibility experience
- Interact effectively and professionally with various levels ofstaff for both internal and external departments, vendors , or Sponsors
- Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate
- Effectively communicates resource, timeline and other DA-Cluster and Product issues as appropriate to the VP, SSRM BU/RU Group Head
- Provides expert guidance to case processing providers' areas on policies and procedures governing the processing of adverse experience information
2
Experience For Drug Safety Manager Resume
- Experience in pharmacovigilance and safety reporting activities (E2B, gateway, local submissions)
- Good working knowledge of financial budgets and various financial analysis tools
- Detailed knowledge of drug safety databases and experience working with MedDRA
- Able to act independently, seeking guidance as appropriate. Demonstrates leadership in day-today activities
- Be the senior strategic leader providing a strong, clear voice for the drug safety program
- Experience with drug safety and pharmacovigilance
- Experience proficiency with drug safety databases and pharmacovigilance regulations
- Physicians graduated from Modern Medicine with 1 or more years of clinical research or industry experience
3
Experience For Drug Safety Physician Resume
- Clinical research/drug safety experience with a CRO
- Build and maintain good working relationships across functional units
- Develops and implement procedures/programs to ensure effective and efficient business and operational processes
- Pharma/biotech experience including 2 years in drug safety and/or pharmacovigilance
- Strong working knowledge of FDA and EU Guidance on Drug Safety
- Experience supporting regulatory submissions desirable but not required
- Experience in compiling adverse event related reports in software for regulatory submission is desired
4
Experience For Specialist, Drug Safety Resume
- Good understating of financial aspects of the project
- Establish and maintain an effective and in–depth pharmacovigilance (PV) training program for national and regional affiliates
- Regularly coach/mentor all permanent direct reports to develop effective Performance
- Demonstrates diligence in responding to requests from Drug Safety staff
- Organizing, planning, leading and delivering the Nexxus Social offering across work-streams to achieve the objectives of the client and internal organizations
- Ensuring the consistency of safety assessment, analysis and reporting for both compounds in development and marketed products
- Collaborating with the student cohort on fundraising and charity events
- Working knowledge and understanding of drug safety data bases (e.g. Argus or ARISg)
5
Experience For Senior Drug Safety Case Manager Resume
- Querying and extracting data out of the global safety database
- Working knowledge of global regulations
- Providing PVRM Medical representation on product specific and/or clinical study team meetings and governance committees
- Conducting duplicate searches to determine if case is initial or follow-up
- Identifying opportunities for Consistency and Standards for SS & RM approaches and
- Working knowledge of global pharmacovigilance regulatory requirements and guidance documents
6
Experience For Medical Director, Drug Safety Resume
- Understanding of local and applicable foreign safety regulations
- Championing high quality SSRM deliverables, and innovation
- Coordinating ICSR collection from MLM service
- Managing the global pharmacovigilance mailbox
- Training and QC
- Maintaining a working knowledge of applicable global regulatory authority regulations
- Receiving, reviewing and processing all reports from various sources (including patient interviews)
- Ensuring timely and adequate follow-up to HCPs and other reporters on adverse event reports & pregnancy reports
7
Experience For Drug Safety Public Health Specialist Resume
- Transferring electronic files to Department’s Shared drive
- Capturing, follow-up and ensure the appropriate persons within Celgene are notified of locally reported Product Quality Complaints
- Presenting drug safety topics for regulatory authorities or at conventions, meetings, etc
- Understanding of and contribution to Takeda business needs and strategy
- Providing support for audits and inspections; involved in inspection readiness activities, as required
- Interacting with internal or external contacts to resolve issues related to the review process
- Perform unblinding step of blinded SUSAR during clinical trial following the confirmation from Medical Evaluation
- Collaborates with contract service providers regarding case processing, aggregate reporting and quality management activities
- Assists with inspection readiness by ensuring documentation is complete and archived, maintaining archive sites, and conducting other activities as assigned
8
Experience For Associate Director, Drug Safety Resume
- Coordinate and implement department training and identify training needs; provide Medical Affairs and Drug Safety training to other departments as requested
- Provide input to Sr. PV Operations Officer on ICSR handling/ data entry/reporting for creation of training material
- On the job training, evaluation and coordination of PV colleagues on case handling and using the global safety database
- Determine the most appropriate monitoring and stopping rules for clinical trial protocols in partnership with the project’s medical monitor
- Balance competing interests of various stakeholders and strive for achieving mutually beneficial and compliant solutions
- Perform coding of medicinal products using WHO Drug Dictionary
- Compliance with archiving tasks for deliverables and important documents related to both postmarketing and clinical trials
9
Experience For Associate Director Drug Safety Operations Resume
- Conduct/support signal detection and evaluation according to standard operating procedures and guidelines
- Information sharing with other departments, e.g. Global Drug Safety, Medical Information, Sales, Medical Affairs, Marketing
- Subject matter expert (SME) regarding SOP drafting and revision
- Informs GPSE on all local 3rd party agreements (e.g. in-licensing or out-licensing of products)
- Focuses intra- and inter- DA-Cluster sharing of information between related areas (e.g. safety knowledge of Pain vs Inflammation co-prescribing)
10
Experience For Drug Safety & Medical Information Officer Resume
- Detailed knowledge of drug safety operations including single case and aggregate data management, and adverse event reporting
- Proficiency in technical safety systems including Celgene’s current central safety database and medical coding
- Give training on drug safety reporting of LOC personnel and maintain awareness of drug
- Data handling of all adverse events and special situations according to appropriate SOP and WI’s
- Demonstrates good analytical thinking skills, attention to detail, teamwork, initiative, and basic project management skills; maintains confidentiality; maintains meticulous attention to project deadlines
List of Typical Skills For a Drug Safety Resume
1
Skills For Senior Drug Safety Physician Resume
- Strong communication skills demonstrated by the ability to ask questions, express opinions and/or offer suggestions for process improvement
- Strong professional inter-personal skills demonstrated by daily interactions with co-workers
- Good knowledge of MS Office (good IT skills)
- Have strong communication skills with a proven ability to negotiate and communicate with both internal and external customers
- Good keyboard skills, preferable with knowledge of MS office and Windows would be beneficial
2
Skills For Drug Safety Manager Resume
- Strong organizational skills, exceptional attention to detail with the ability to adapt and deal with change
- Working effectively when co-located with, and when remote from, product teams/leaders/managers and reports
- Ability in, and track record of, working effectively in an advanced matrix structure including matrix team leadership/representation
- S/he needs to be have proven experience in business, process and financial compliance processes, such as account payable and contracting
- Managerial skills - planning, organising, decision making and problem solving
3
Skills For Drug Safety Physician Resume
- Prior relevant experience
- Organizational, written and verbal communication skills
- Work effectively at the management as well as at an individual contributor level and as a project team member
- Solid experience in Drug Safety/Pharmacovigilance to include work with either a European or Global remit
- No (specific) experience required, but experience in Drug Safety is an asset
- Good knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
4
Skills For Specialist, Drug Safety Resume
- Great communication skills; a pro-active team player to be the key link between the business and the client
- Strong knowledge of and experience with advanced Microsoft Excel and Access
- In depth proven clinical research or industry experience
- Interact effectively and professionally with various levels of staff for both internal and external departments, vendors , or Sponsors
- Works effectively, independently and collaboratively
- Communicates effectively to ensure relevant parties are fully informed and knowledgeable of project activities and their status
- Ensure effective cross-functional global teamwork and maintain good team relationship across functional units
- MS/MA +3 to 4 years relevant experience (2-3 years safety experience)
- To contribute effectively as part of the Celgene Global Safety network
5
Skills For Senior Drug Safety Case Manager Resume
- Enabling WWS pan-BU prioritization of resources, rapid re-deployment/refill/dual deployment
- Maintaining excellent knowledge of the safety profile of the assigned products, client procedures and international drug safety regulations
- Working knowledge of Good Pharmacovigilance Practice (GPV) modules
- Experience developing/facilitating/delivering learning solutions
- Provides expert guidance to case processing providers areas on policies and procedures governing the processing of adverse experience information
6
Skills For Medical Director, Drug Safety Resume
- Captures the incoming information into Siebel or tracking database prior to distribution to the Case Management group
- Can handle more than one complex project simultaneously, prioritizing well and recognizing key issues
- Experience in the management of safety information originating from both clinical trials and post-marketing sources
- Experience in assessing competency gaps and identifying what people need to learn for successful individual and organizational performance
- Five to seven years’ experience in pre-marketing and post- marketing drug safety
- Strong understanding of regulatory (FDA, EMA, MHRA) guidelines around the reporting of adverse events, PQC’s etc
- Pharma/biotech experience including 4 years in drug safety and/or pharmacovigilance
- Self-Management, Results Oriented, Prioritizing possibilities and opportunities
- Able to make effective decisions while managing multiple workload
7
Skills For Drug Safety Public Health Specialist Resume
- Experience with aggregate safety reporting and quality management in pre- and post-approval periods
- Have a proven ability to organize workflow activities while managing multiple critical issues
- Proven ability to interact well in a multifunctional team setting
- Client facing experience advantageous
- Attention to detail and ability to be flexible in order to meet daily competing priorities of the business
- Demonstrate leadership and proficiency managing across organizations
8
Skills For Associate Director, Drug Safety Resume
- The ability to thrive in a changing environment and to re-prioritize workload after business needs
- Recommends corrective plans to alleviate significant deviations from research priorities, protocols, staffing, budgets and schedules
- Completes AE reconciliation and ensures AE identification effectiveness sampling consistent with global procedures and forwards any AEs identified to PPS
- Experience with relevant safety databases and related software applications
- Proven ability to perform task management
9
Skills For Associate Director Drug Safety Operations Resume
- Demonstrate flexibility within a dynamic, fast-paced, cross-functional team
- Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment
- Good working knowledge of English, French and Dutch
- Proven in depth knowledge of local safety and regulatory requirements
- Identify, prioritize, and monitor quality issues to be resolved to maintain compliance
- Ph.D or D.V.M. with at least seven years of experience in analytical chemistry, biochemistry, or a closely-related discipline
- Six years’ experience in Drug Safety/Pharmacovigilance to include work with either a European or Global remit
- Experience in computer software packages including Microsoft applications
- Demonstrated ability to think strategically and communicate complex issues clearly
10
Skills For Drug Safety & Medical Information Officer Resume
- Good knowledge of drug safety and the drug development process
- Drug safety experience
- Be able to demonstrate your knowledge of all local Pharmacovigilance requirements and global aspects of drug safety
- Good knowledge of the relevant worldwide pharmacovigilance regulations and guidelines
- Good knowledge of ICH guidelines
- Good knowledge of medical and drug terminology
List of Typical Responsibilities For a Drug Safety Resume
1
Responsibilities For Senior Drug Safety Physician Resume
- + Good verbal, written and presentation skills
- Effectively communicate (verbal and written) and defend safety findings and recommended risk management and minimization activities
- Language skill: Swedish (fluent), English (excellent)
- Ensures effective review, reporting and follow-up of any adverse events or product complaints
- Good understanding of drug safety
2
Responsibilities For Drug Safety Manager Resume
- Experience in global clinical/regulatory/PV operations
- Oncology experience desired
- Industry experience in Safety and Pharmacovigilance
- Experience in Drug Safety / Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency
- + Industry experience of which 4 years is relevant to phannacovigilance/drug safety knowledge
- + Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
3
Responsibilities For Drug Safety Physician Resume
- Strong knowledge base of pharmacovigilance principles
- Strong knowledge base of pharmacovigilance regulations
- Some experience in in-depth literature research, analysis and interpretation of medical data required
- Strong commitment to compliance with relevant regulation, procedures, and to scientific quality and integrity
- Good team player that also can work independently
- Planning, organizing, and managing daily work to meet service level timelines and deliverables
- Ensuring adequate source documentation (filing/administration is supported by PV data entry contractor and medical assistant)
- Designing and develop training materials
- Leveraging DA focused expertise flexibly into all BUs, and deployment to Due Diligence inlicensing assessments
4
Responsibilities For Specialist, Drug Safety Resume
- Assigning the "right colleague to the right project at the right time"
- Assisting the Director/Senior Director to develop and grow capabilities, productivity, and quality levels
- Provide training of Biogen personnel and external vendors on adverse event collection and reporting processes
- Assist in the maintenance of files regarding adverse event reporting requirements in all countries
- Work within the Standard Operating Procedure (SOP) system, including departmental Work Instructions
- Assist in preparing and responding to Regulatory Agency Inspections as well as internal and external audits as applicable
- Preparation, analysis and writing of ad hoc and aggregate regulatory reports and labeling support document
5
Responsibilities For Senior Drug Safety Case Manager Resume
- Knowledge of global post marketing safety reporting regulations and guidance
- Deliver face-to-face training for national and regional PV teams worldwide for existing regulations/policies and procedures
- Track training and training records
- Assesses emerging safety profile of products by reviewing all relevant safety parameters
- Participates in focused drug safety functions and drug safety operations including independent data monitoring boards, and external consultant discussions
- Continually looking for ways to change or improve a process, focusing on efficiency
- SSRM providing consistent direct line Management of the colleague matrix supporting all BUs
6
Responsibilities For Medical Director, Drug Safety Resume
- Be aware of post-authorisation safety studies requested by a competent authority including the results of such studies
- Assist in the processing of expedited safety reports (ESRs)
- Supervise, support and train staff, and identify resource and system needs to ensure compliant and quality case processing and safety data management practices
- Develops and maintains progress tracking systems for action items and follow up to ensure timely reply or action
- Ensures a local tracking system is in place, to ensure timely submissions of adverse events to AbbVie PPS
7
Responsibilities For Drug Safety Public Health Specialist Resume
- Maintains awareness of local post-marketing and clinical PV legislation
- Reviews and confirms regulatory reporting requirements at least annually
- Provide support and training in topics related to PV Business Group
- Process incoming requests from internal and external sources related to PV requirements and initiate appropriate course of action and/or response
- Participates in overseeing the preparation and management of medical safety documents submitted to the FDA
- Responsible for meeting defined expectations and commitments on a therapeutic program
8
Responsibilities For Associate Director, Drug Safety Resume
- Gives medical support, advise and expertise regarding clinical issues
- Expert at ensuring scientific quality and timeliness of all documents
- Ensure timely reporting to competent authorities and safety partners
- Coordination of Pregnancy Follow Ups Continuous updating of all relevant documents and Overviews (e.g. lists for literature search,...)
- Be able to work in a matrix environment whilst remaining organized at all times
- Define and manage internal resources and third parties/vendors at a study level, proving feedback to upper management as needed
9
Responsibilities For Associate Director Drug Safety Operations Resume
- Work with the Aggregate Reporting team lead to escalate issues or tasks outside the normal scope of work
- Ensure timely receipt of adverse event reports by regular monitoring of fax machines and email systems
- Assist with local literature screening for adverse event information
- Create recorded instructor-lead training
- Perform project management and logistics for face-to-face training meetings
- Responsible for meeting manager-defined Drug Safety lead expectations and commitments on a therapeutic program assigned
- Supports members of drug safety team and project teams- Gives medical support, advise and expertise regarding clinical issues
- Safety representative in interactions with Array co-development and co-marketing partnerships
- Perform coding of adverse events, indications, medical history/conditions
10
Responsibilities For Drug Safety & Medical Information Officer Resume
- Perform End of Study Unblinding
- Support the RM Lead in responding to safety requests for assigned product(s) from Regulatory Authorities, Affiliates, and other internal functions
- Attend weekly SS&E meeting to relay safety concerns raised in Study Team/Clinical Sub Team Meetings
- Review all documents assigned for scientifically/medically relevant issues including drug
- Provide support to Medical Information regarding safety questions
- Create or contribute to standard operating procedures (SOP) and guidelines
- Familiarity with GCP and with clinical trial and post marketing regulations
- Review all documents assigned for scientifically/medically relevant issues including drug safety
- Provides safety operations support for external submissions, signal detection and future risk management planning activities
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