Qualified Person – Pharmacovigilance (EU)
Thermo Fisher Scientific
Descrição do cargo
About the role
Thermo Fisher Scientific is seeking an experienced Qualified Person (QPPV) for Pharmacovigilance in the European Union. The role will support selected clients by ensuring compliance with EU pharmacovigilance legislation and delivering high‑quality safety services.
Key responsibilities
- Act as EU and/or UK QPPV or Deputy QPPV for designated clients, complying with EU Directive 2001/83/EC and related guidance.
- Provide scientific safety services such as safety writing, signal detection, and literature surveillance.
- Oversee national contact persons where applicable and promote best practices within the department.
- Contribute to client proposals, present at business development meetings, and help expand QPPV service offerings.
- Manage scope of work, budgets, and resourcing for both new and existing QPPV engagements.
- Analyse complex safety issues, define methods and procedures, and coordinate activities of team members.
Required profile
- Master’s degree in Pharmacy, Medicine or an equivalent qualification.
- Previous experience as an EU/UK Qualified Person for Pharmacovigilance.
- At least 5 years of EU‑specific pharmacovigilance experience, including regulatory inspection exposure.
Required skills
- In‑depth knowledge of EU pharmacovigilance regulations (Directive 2001/83/EC) and CRG procedures.
- Expertise in safety writing, signal detection, and literature surveillance.
- Experience with pharmacovigilance regulatory inspections.
- Ability to establish drug‑safety processes and build expertise within teams.
What we offer
- Opportunities for continuous career advancement within a global life‑science leader.
- Award‑winning training programs and professional development resources.
- Comprehensive health, wellbeing and benefits packages.
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Expira em 2 semanas
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