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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 background in clinical trial oversight, regulatory compliance, and risk management. Capable of providing medical consultation and conducting thorough reviews of safety documentation and clinical data.
Highest-signal resume keywords
Medical Degree7+ Years Clinical Practice ExperiencePharmaceutical Industry ExperienceKnowledge of Clinical TrialsValid Medical License
ATS Keywords
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Hard Skills
Pharmacovigilance ServicesMedical Review of Adverse EventsAggregate Safety ReviewsRegulatory Safety ReportsRisk Management PlansData Safety MonitoringSignal Management ActivitiesClinical Trial Document ReviewCoding Review of Medical DataBenefit-Risk Assessments
Soft Skills
Effective CommunicationConsultation SkillsInitiativeFlexibilityRelationship Building
Certifications & Qualifications
Valid Medical License
Industry Keywords
Clinical Research RegulationsGood Clinical PracticeSafety DocumentationIntegrated Safety SummariesCommon Technical Documents
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 standalone safety projects with appropriate oversight.
- Perform medical review and clarification of trial-related Adverse Events and post-marketing adverse drug reactions, including narratives, queries, coding, expectedness, seriousness, causality and company summary.
- Compose, edit and medically review Analyses of Similar Events for expedited cases.
- Serve as an internal consultant to pharmacovigilance case processing teams.
- Provide aggregate reviews of safety information and clinical data to maintain oversight of product safety profiles.
- Provide coding review of adverse events, medical history, concomitant medications and other medical data listings.
- Represent safety and clinical data review findings during client meetings.
- Review and edit regulatory safety reports, risk management plans, benefit-risk assessments and related safety documentation.
- Provide medical oversight for label development, review and change.
- Support Data Safety Monitoring Board meetings and Safety Monitoring Committees.
- Contribute to Integrated Safety Summaries and Common Technical Documents.
- Review and sign off on Project Safety Plans and Medical Monitoring Plans.
- Review protocols, Investigative Drug Brochures and Case Report Forms for appropriate safety content and data capture.
- Act as Global Safety Physician, Assistant or Back-up on assigned projects.
- Attend project, medical safety team and client meetings as requested.
- Ensure coverage for medical safety deliverables within regulatory or contracted timelines.
- Provide medical escalation support for medical information projects and EU Qualified Persons for Pharmacovigilance projects.
- Provide 24-hour medical support as required on assigned projects.
- Maintain awareness of medical-safety-regulatory industry developments.
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.