Senior Pharmacovigilance Manager, QPPV Office

This is a fully remote position, open to applicants in Germany, +2 more countries.

📋 Description

• Lead a team of Pharmacovigilance (PV) Consultants and PV Coordinators to provide both local and global pharmacovigilance services.

• Act as the Qualified Person for Pharmacovigilance (QPPV) or Local Person for Pharmacovigilance (LPPV) for ProPharma clients, which includes serving as the Graduated Plan Officer in Germany or the National Contact Person in the UK.

• Serve as a subject matter expert in designated pharmacovigilance domains.

• Assist with recruitment, onboarding, performance evaluations, development planning, succession planning, coaching, and training initiatives.

• Oversee QPPV/LPPV projects to ensure they are completed on time, within budget, and to the requisite quality standards.

• Track expenses, team utilization, workload, staffing, and resource management.

• Resolve workflow discrepancies, identify bottlenecks, address team challenges, and eliminate obstacles.

• Partner with Business Development and Client Services on budgetary proposals.

• Participate in bid defense meetings with prospective clients as necessary.

• Supervise the implementation and operational execution of both global and local PV services.

• Revise QMS documentation, client-specific Working Practices, and related Work Instructions.

• Create and provide training on pharmacovigilance topics.

• Assist with client audits and inspections.

⛳️ Requirements

• A University Degree (BSc EQF level 6, MSc EQF level 7, or PhD EQF level 8) in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry, nursing, life sciences, medical technology, or biology.

• At least 5 years of experience in clinical and/or post-marketing pharmacovigilance.

• A minimum of 2 years of experience in a QPPV office role.

• Proven experience in leading and developing a project team.

• In-depth knowledge of global pharmacovigilance practices and regulatory frameworks, including MHRA and EU PV legislation and guidance.

• Exceptional written and verbal communication abilities.

• Strong planning, prioritization, and organizational capabilities.

• Excellent decision-making and problem-solving skills.

• Proficient in liaising and negotiating effectively with clients.

• Ability to delegate tasks efficiently.

• A strong commitment to continuous improvement in processes, procedures, and business operations.

• High attention to detail and a focus on quality.

• Capability to manage multiple projects simultaneously.

🏝️ Benefits

• Hybrid working arrangements are encouraged for new hires residing within a reasonable commuting distance from an office.

• Commitment to diversity, equity, and inclusion.

• Equal Opportunity Employer.

• A safe and empowering workplace environment.

• Every applicant will receive communication regarding the outcome of their application.