Associate Director, Pharmacovigilance - Safety Scientist
PTC Therapeutics · Guildford, UK +2 more
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
PTC Therapeutics seeks an Associate Director of Pharmacovigilance to serve as a Safety Scientist managing clinical trial and post-marketing surveillance activities. The role involves leading aggregate safety report development, coordinating cross-functional stakeholders, and ensuring compliance with global pharmacovigilance regulations.
What they're looking for
- Bachelor of Science in Nursing, Pharmacy, or related life science discipline
- Minimum 8 years of progressively responsible pharmacovigilance experience
- Expert knowledge of FDA, EU, and ICH guidelines and regulations
- Extensive working knowledge of medical terminology and MedDRA
- Scientific writing and project management experience
- Proficiency with Microsoft Office and excellent communication skills
- Ability to work independently and collaboratively in matrixed environments
What you'll be doing
- Manage product-specific pharmacovigilance activities and aggregate safety reports
- Project manage compilation of DSURs, PBRERs, and other regulatory safety documents
- Collaborate with safety physician and cross-functional teams to meet regulatory reporting deadlines
- Lead and oversee safety review board planning and risk management plan updates
- Provide technical and scientific oversight for safety surveillance and signal detection activities
Privacy & handoff
This role links to PTC Therapeutics's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.