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About the role
Key responsibilities & impact- Join our Pharmacovigilance team as Associate Director International PV.
- Responsible for the leadership and oversight of the international PV office.
- Ensure compliance with international regulations, guidelines, and internal quality standards.
- Oversee and manage a team of EU/UK QPPVs and PV personnel.
- Support operational, financial, and client objectives of the sub-department.
- Drive process excellence and effective management of PV operational activities.
- Influence the performance of the quality system and PV activities.
- Oversee sub department forecasting and contribute to budget planning.
- Manage PV projects and customer activities, supervising core PV deliverables.
- Ensure oversight of the contractual partner safety data exchange agreements.
- Oversee inspection/audit strategy, readiness, and finding remediation.
- Monitor regulatory changes and ensure PV compliance across assigned projects.
- Manage assigned team, set goals, evaluate performance, and support decisions on promotions.
- Identify areas for improvement and proactively propose solutions.
Requirements
What you’ll need- Biologist, Pharmacist, Medical Doctor, or other life science degree
- At least 6 years of work experience in PV functions and 1 year of experience in managing PV teams
- Team management experience
- Excellent knowledge of international regulations (ICH, EU GVP Modules, UK guidelines, FDA)
- Experience in PV Medical writing and Project management skills
- Demonstrated ability to accurately and effectively evaluate, interpret and present safety data and to interpret and apply global safety regulations
- Demonstrated ability to implement PV strategies and develop PV systems and procedures
- Professional level in English, both in oral and written communications
- Demonstrate strong leadership and collaboration skills by effectively leading and aligning cross-functional teams
- Advanced decision-making and problem-solving skills
- Strong communication and leadership skills
Benefits
Comp & perks- Professional growth and career opportunities
- International team and environment
- Bonus based on annual performance
- Personal accident and business trip insurance
- Additional health insurance
- Remote/home-based position
- Rewarding referral policy
- Workplace establishment allowance
- Team building, global meetings, B active events
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
PharmacovigilancePV Medical writingProject managementSafety data evaluationGlobal safety regulationsPV strategies implementationPV systems developmentBudget planningProcess excellenceTeam management
Soft Skills
LeadershipCollaborationDecision-makingProblem-solvingCommunicationPerformance evaluationGoal settingInfluencingProactive improvementCross-functional alignment
