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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical risk management, pharmacovigilance, and safety surveillance for investigational and marketed products, with a strong focus on regulatory compliance and safety data analysis.
Highest-signal resume keywords
Clinical Risk ManagementPharmacovigilanceSafety Data AnalysisRegulatory Document PreparationOrganizational Leadership
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical DevelopmentRisk Management PlansSafety Assessment ReportsAggregate Clinical Trial Data AnalysisMedDRA KnowledgeDrug Safety SurveillancePeriodic Safety Update ReportsCTD ComponentsSafety SummariesSafety Surveillance Activities
Soft Skills
Excellent CommunicationAnalytic SkillsOrganizational Leadership
Certifications & Qualifications
MDDOBoard Certification
Industry Keywords
Clinical SafetyDrug DevelopmentRegulatory AffairsEpidemiologySafety Information Completeness
About the role
Key responsibilities & impact- Lead overall clinical risk management and safety surveillance for assigned investigational and marketed products
- Chair Risk Management Safety Teams and lead development and maintenance of risk management and pharmacovigilance plans
- Participate in Product Development Teams, internal and joint internal/external research teams, and related sub-teams
- Partner with clinical development and clinical research to support robust safety assessment and benefit-risk evaluation
- Collaborate with clinical development, epidemiology, regulatory affairs, statistics, and manufacturing teams on safety topics
- Evaluate safety data from clinical trials, literature, and post-approval use
- Ensure completeness of safety information in company core data sheets
- Develop scientific strategy for safety-related documents, including CTD components, Risk Management Plans, and Periodic Safety Update Reports
- Ensure safety sections of product circulars are medically and scientifically appropriate
- Conduct aggregate clinical trial data analyses and post-approval safety signal reviews
- Oversee safety surveillance activities with the CSRM Associate
- Recommend pharmacovigilance actions, labeling changes, risk management plans, and risk minimization activities
- Review and approve product labeling files in the safety database using MedDRA knowledge
- Prepare safety summaries and analyses for regulatory documents, aggregate reports, and regulatory filings
- Supervise CSRM medical associates in safety data analysis and regulatory document authoring as needed
- Participate in developing, implementing, and evaluating department standards, processes, metrics, and initiatives
Requirements
What you’ll need- MD, DO, or equivalent required
- Minimum of 3 years clinical experience following post-graduate medical training or other relevant clinical experience
- Prior experience in drug development, including clinical development and/or regulatory experience
- Experience in clinical safety, pharmacovigilance and/or risk management
- Demonstrated organizational leadership skills, preferably in the noted employment areas
- Excellent communication, writing, and analytic skills
- Knowledge of Clinical Development, Clinical Risk Management, Clinical Safety, Clinical Training, Drug Development, Drug Safety Surveillance, Pharmacovigilance, Regulatory Documents, Risk Management, and Safety Assessment Reports
- Board Certification preferred
- Must be a US or Puerto Rico resident
- No visa sponsorship available
Benefits
Comp & perks- Annual bonus
- Long-term incentive, if applicable
- Medical, dental, and vision healthcare
- Other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Remote work arrangement
- Relocation not provided