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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 and safety surveillance, with a strong focus on safety data evaluation and regulatory documentation. Proven ability to lead cross-functional teams and manage pharmacovigilance activities effectively.
Highest-signal resume keywords
Medical Doctor (MD)Clinical ExperienceSafety ExperiencePharmacovigilanceAggregate Data Analysis
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Safety Data EvaluationRisk Management Plans (RMP)Periodic Safety Update ReportsCausality AssessmentSafety Document Authoring
Soft Skills
Organizational LeadershipExcellent CommunicationEffective PresentationProblem SolvingConflict Resolution
Industry Keywords
Clinical Risk ManagementSafety SurveillanceCross-Functional CollaborationPost-Approval Safety SignallingSafety Summaries
About the role
Key responsibilities & impact- Lead the overall clinical risk management and safety surveillance of assigned marketed products
- Chair the Risk Management and Safety Team (RMST) for assigned products
- Participate in internal and joint internal/external research project teams
- Collaborate with cross-functional team members including clinical development, epidemiology, regulatory affairs, statistics, and manufacturing
- Conduct safety data evaluation, assessing safety from multiple sources (clinical trials, literature, post-approval use)
- Accountable for scientific strategy for safety related documents (e.g. Risk Management Plans (RMP) and Periodic Safety Update Reports)
- Responsible for safety surveillance activities such as aggregate data analysis and post approval safety signalling reviews
- Collaborate with CSRM Associate to oversee all safety surveillance activities
- Contribute to recommendations for pharmacovigilance actions and developing risk minimization activities
- Prepare safety summaries and analyses of safety related data for regulatory documents
Requirements
What you’ll need- Medical Doctor (MD)
- Minimum of 2-3 years clinical experience (in a patient care setting) following post-graduate medical training or other relevant clinical experience
- Minimum 7 years of professional experience with both clinical and pharmaceutical industry experience required, of which a minimum of 4 years MUST include safety experience (e.g. PV or clinical) involving causality assessment, analysis of aggregate safety data and/or authoring of safety documents
- Demonstrated organizational leadership skills
- Excellent communication, and writing skills in English
- Demonstrated skills in managing programs, processes, and facilitating meetings
- Effective presentation skills and experience influencing and negotiating
- Problem solving, conflict resolution and critical thinking skills
Benefits
Comp & perks- Flexible Work Arrangements: Hybrid
- Professional development opportunities
- Health insurance
- Relocation assistance
