Senior Pharmacovigilance Manager, QPPV Office

🔥 2 minutes ago

🌐 Germany, Netherlands, +1 more countries – Remote

🇩🇪 Germany – Remote 🇳🇱 Netherlands – Remote 🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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ProPharma

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 2001

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

💰 $8.6M Venture Round on 2020-10

Healthcare • Logistics • Manufacturing

ProPharma is a leading research consulting organization in the life sciences industry. The company specializes in providing custom solutions across the full product lifecycle, from early discovery to post-market monitoring. ProPharma's services include regulatory sciences, clinical research solutions, quality and compliance services, pharmacovigilance, medical information, and R&D technology. Known for its deep domain expertise, ProPharma assists clients in the pharmaceuticals, biotechnology, and medical device sectors with regulatory support, clinical development, and quality management. ProPharma's global team supports a wide range of therapeutic areas including oncology, cardiovascular, and rare diseases, among others, ensuring effective and efficient delivery of life-saving therapies.

📋 Description

• Lead a team of PV Consultants and PV Coordinators supporting local and global pharmacovigilance services • Serve as QPPV or LPPV for ProPharma clients, including Graduated Plan Officer in Germany or National Contact Person in the UK • Act as subject matter expert for assigned pharmacovigilance areas • Support hiring, induction, performance reviews, development planning, succession planning, coaching, and training • Manage QPPV/LPPV projects within budget, on time, and to required quality standards • Monitor expenses, team utilization, workload, staffing, and resource allocation • Address workflow deviations, bottlenecks, team issues, and roadblocks • Collaborate with Business Development and Client Services on budget proposals • Attend bid defense meetings with potential clients as required • Oversee implementation and operational delivery of global and local PV services • Update QMS documentation, client-specific Working Practices, and associated Work Instructions • Develop and deliver pharmacovigilance training • Support client audits and inspections

🎯 Requirements

• 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 science, medical technology, or biology • Minimum of 5 years’ experience in clinical and/or post-marketing pharmacovigilance • Minimum of 2 years’ QPPV office experience • Experience leading and developing a (project) team • Expert knowledge of global pharmacovigilance practices and regulatory requirements, including MHRA and EU PV legislation and guidance • Excellent written and oral communication skills • Excellent planning, prioritization, and organizational skills • Excellent decision-making and problem-solving skills • Ability to liaise and negotiate efficiently with clients • Ability to delegate effectively • Strong focus on continuous process, procedure, and business improvement • Excellent attention to detail and focus on quality • Ability to manage multiple projects

🏖️ Benefits

• Hybrid working encouraged for new hires within a reasonably short commute of an office • Diversity, equity, and inclusion commitment • Equal Opportunity Employer • Safe and empowering workplace • Application outcome communicated to every applicant

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