Director, Drug Safety and Pharmacovigilance
Jocelyn Blackham is recruiting for a Director, Drug Safety and Pharmacovigilance to join an exciting Swiss biopharmaceutical company with a strong pipeline and launches on the horizon. Their site is based just outside of Basel and this position is offered on a permanent basis.
Director, Drug Safety and Pharmacovigilance Role:
- Accountability for all aspects of safety related to the assigned projects/products including medical assessment, aggregate reporting, signal detection, risk management, and risk minimization activities throughout the product’s life cycle.
Leading the cross-functional Safety Management Team (SMT) for assigned projects/products; responsible for the integration, analysis, and interpretation of safety information from all sources, including preclinical throughout life cycle product management.
Coordinates and ensures good quality presentation by the SMT at company’s Drug Safety Committee (DSC), with an accurate review of the safety profile of the product including presentation of implemented safety measures and SMT recommendations
Key duties will include:
Responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information.
Represents the company’s in interactions with Health Authorities and Independent Data Safety Monitoring Board activities for safety related topics.
- Responsible for the preparation of aggregated periodic safety reports: DSUR, PSUR/PBRER, Reference Safety Information (RSI) section of the Investigator Brochure (IB) and contribute to other key regulatory key safety documents such as Integrated Summary Safety (ISS), RMP/Risk Evaluation and Mitigation Strategy (REMS).
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
Doctor of Medicine degree with a wealth of experience in clinical and post-marketing safety and/or clinical development in the pharmaceutical or biotechnology industry.
A full understanding of the Clinical trials and post-marketing adverse experience reporting systems, experience in product safety monitoring and preparation of investigational and post-marketing regulatory safety reports/documents.
Previous experience with regulatory filing and contribution to key safety documents such as Integrated Summary Safety document, Development Safety Update Report (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Risk Management Plan (RMP), Company Core Data Sheet (CCDS) etc.
Previous experience with Argus Safety database is preferable.
This exciting opportunity offers a hybrid model (3 days on site, 2 days from home); a great salary and package including a bonus and share options.
For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 800 106 106 or email jblackham@ckqls.ch. Please could you send any correspondence in English. Please quote reference 54067 in all correspondence.
