- Posted 31 January 2024
- Job type Permanent
- Contact NameDominic Pritchard
BioTalent is collaborating with a well respected Big Pharma company to expand the Drug Safety/Pharmacovigilance team by appointing a Senior Director - Safety Physician.
The role has a hybrid working model with offices in Switzerland. Preferable profiles will have successful track record in PV including submissions and interacting with the regulatory authorities (on a global level). Already living or working in Switzerland will be most desirable.
You will play a pivotal role in clinical development, acting as the global safety lead for assigned compounds and leading the development and execution of benefit-risk management strategies.
- Chair the product Safety Management Team, overseeing, preparing, and reviewing benefit risk, CTD, MAA, aggregate safety review documents etc
- Develop, evaluate and manage signals, actively participate in Health Authority and Data Monitoring Committee meetings.
- Lead safety labelling activities for assigned products/programs, act as the Safety Subject Matter Expert for regulatory product labelling, and support the EU QPPV.
- Drive process improvement projects, supporting R&D publication strategy/plans, and ensuring safety input to publications/presentations.
MD +/- with a postgraduate qualification
Extensive industry experience in pharmacovigilance
Key understanding of the drug development process and regulatory requirements for safety assessment.
If this role is for you please reach out to firstname.lastname@example.org +41415625046