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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in pharmacovigilance and medical safety, with a strong focus on regulatory compliance, clinical trial oversight, and risk management. Proficient in medical review processes, including adverse event analysis and safety reporting.
Highest-signal resume keywords
Pharmacovigilance ExpertiseClinical Trial OversightRegulatory ComplianceRisk ManagementMedical Review and Analysis
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Adverse Event ReviewAggregate Report CreationSignal ManagementClinical Data AnalysisCoding ReviewMedical Safety EvaluationProtocol ReviewRisk Evaluation and Mitigation StrategiesDevelopment Risk Management PlansIND Annual Reports
Soft Skills
Effective CommunicationConsultation SkillsRelationship BuildingInitiativeFlexibility
Certifications & Qualifications
Medical License
Industry Keywords
Clinical ResearchGood Clinical PracticePharmaceutical IndustrySafety MonitoringRegulatory Guidelines
About the role
Key responsibilities & impact- Provide medical expertise on pharmacovigilance services to divisions as requested.
- Participate in all aspects of Medical Safety’s involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors.
- Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary.
- Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements.
- Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported.
- Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile.
- Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data.
- Represent safety and clinical data review findings during client meetings.
- Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports.
- Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies.
- Provide medical oversight for label development, review and change.
- Provide medical support and attendance at Data Safety Monitoring Board Meetings.
- Attend and contribute medical safety evaluation on Safety Monitoring Committees.
- Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document.
- Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments.
- Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract.
- Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture.
- Act as Global Safety Physician or Assistant or Back-up on projects as assigned.
- Attend project meetings, medical safety team meetings, and client meetings as requested.
- Ensure coverage for all medical safety deliverables within regulatory or contracted timelines.
- Provide medical escalation support for medical information projects.
- Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects.
Requirements
What you’ll need- Medical degree from an accredited and internationally recognized medical school (Bachelor's Degree in Medicine necessary).
- 7+ years of clinical practice experience: Signal management activities, review clinical trial documents, creation, analysis, and presentation of reports (aggregate reports), client facing activities, risk management.
- 9+ additional years in the pharmaceutical or associated industry.
- Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice.
- Knowledge of clinical trials and pharmaceutical research process.
- Ability to establish and meet priorities, deadlines, and objectives.
- Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- A valid medical license, or equivalent, from the country or region in which he/she resides and works.
Benefits
Comp & perks- 24 hour medical support as required on assigned projects
- Maintain awareness of medical-safety-regulatory industry developments