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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive pharmacovigilance expertise, including risk management planning, safety data interpretation, and regulatory compliance within the EU. Proven ability to collaborate cross-functionally and manage multiple projects while ensuring product safety and adherence to regulatory standards.
Highest-signal resume keywords
Pharmacovigilance ExperienceRegulatory Affairs ExperienceRisk Management PlanningCross-Functional CollaborationSafety Data Interpretation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
PharmacovigilanceRisk Management Plans (RMPs)Periodic Safety Update Reports (PSURs)Product Safety Risk AssessmentSignal ManagementRegulatory SubmissionsSafety VariationsHealth Authority InteractionsDocument Review and ApprovalCompliance Documentation
Soft Skills
Decision-MakingProblem SolvingIndependent ThinkingJudgmentEffective Communication
Certifications & Qualifications
Bachelor's Degree in Medicine or Healthcare
Industry Keywords
Contract Research OrganizationPharmaceutical IndustryEuropean Union RegulationsSafety CommunicationsRisk Minimisation ActivitiesHealth Authority GovernanceProduct Benefit-Risk AssessmentSignal-Adjudication DiscussionsPSMF ManagementPRAC-Related Activities
About the role
Key responsibilities & impact- Assist the QPPV in analysing, anticipating, and communicating the impact of emerging regulations on company pharmacovigilance processes and product portfolio management
- Contribute to construction of pharmacovigilance regulatory guidance
- Advise and guide functions to help ensure the pharmacovigilance system required by EU regulations and guidance is properly implemented
- Ensure and verify that information in the PSMF accurately and currently reflects the pharmacovigilance system under the QPPV’s responsibility
- Evaluate risks, communicate global impact issues to the QPPV, and recommend action plans
- Participate in mandatory client governance meetings
- Assist in developing the client reputation at health authority level
- Review and advise on management of product-related safety matters affecting patient health and product benefit-risk
- Provide periodic updates on product-related issues to the QPPV
- Timely review and/or approve documents intended for regulatory authority submissions
- Perform other tasks assigned in line with the overall QPPV role
Requirements
What you’ll need- At least a Bachelor's Degree from an accredited and internationally recognized institution in Medicine or another healthcare professional degree with a curriculum relevant to this position
- 5 years’ experience in a Contract Research Organization or Pharmaceutical or associated industry, or equivalent combination of education, training and required experience
- Broad pharmacovigilance experience, including review and contribution to RMPs and additional risk minimisation measures, DHPC preparation and distribution, safety variations, PSURs/PBRERs, the PSMF, PRAC-related activities, referral procedures, and product alerts
- Previous exposure to safety profile oversight and signal management, including review and interpretation of safety data and participation in Safety Management Team and signal-adjudication discussions
- Previous interactions with health authorities, particularly regarding safety communications, DHPCs, risk minimisation activities, referral procedures, and other regulatory activities with a safety impact
- Regulatory affairs experience across both centralised and national procedures
- Strong cross-functional collaboration, particularly with regulatory affairs and other stakeholders involved in product safety assessment and decision-making
- Ability to maintain a comprehensive overview of product safety, identify potential safety risks or compliance concerns, and ensure appropriate escalation, follow-up, and documentation
- Ability to work on multiple projects and manage competing priorities effectively
- Strong judgment, independent thinking, decision-making and problem solving skills
- Must permanently reside and work within the European Union or European Economic Area