Debiopharm Group™ (Debiopharm) is a Swiss-based biopharmaceutical group of four companies active in drug development, GMP manufacturing of proprietary drugs, diagnostics, and investment management. Debiopharm International SA searches, evaluates and in-licenses promising drug candidates for development. Towards the end of the development process, the products are licensed out to pharmaceutical companies for worldwide marketing and sales.
For our Clinical Reseach & Development department based in Lausanne we are looking for a
Director, Head of Pharmacovigilance
Develop and lead all pharmacovigilance (PV) activities within Debiopharm for Clinical Development programs and Commercial products.
Your main responsibilities
- Lead the PV team and develop PV organization capabilities.
- Manage external PV vendors (CROs), ensuring service quality and cost-effectiveness. Balance internal resources and outsourcing in alignment with the company needs and business model.
- Monitor the relationship with commercial partner(s) regarding joint PV activities.
- Organize and monitor the processing and medical review of Individual Case Safety Reports (ICRs) for Debiopharm compounds in clinical development and post-marketing. Discuss the ICSRs with the Project Medical Directors and ensure the timely reporting to the Authorities / clinical sites / partners.
- Evaluate the safety profile of Debiopharm compounds: in collaboration with the different company experts and/or partners/vendors, evaluate and update the risk-benefit profile of Debiopharm compounds (post-marketing and in development), write periodic safety reports (Development Safety Update Reports (DSURs), Periodic Safety Update reports (PSURs).
- Manage the signal detection activities and risk management plan for the different compounds. Perform signal evaluation & validation.
- Manage PV activities according to the existing Safety Data Exchange Agreements (SDEAs). Update the SDEAs if necessary.
- Secure the maintenance and the accuracy of the PV database
- Report regularly pharmacovigilance activities to the VP of the Clinical Research & Development Department and to the Project/Clinical Study Teams. Be the link with Debiopharm Research & Manufacturing.
- Review and Maintain the Standard Operating Procedures (SOPs) / Operating Instructions (OIs) / Pharmacovigilance System Master File (PSMF) up to date.
- Maintain up to date expertise in pharmacovigilance and develop the expertise of the PV team.
- Organize the participation of a PV member in the Project teams / Clinical Study teams according to the request of Project / Study team manager.
- Participate in the Clinical Study Protocol & Investigator Drug Brochure writing/review with regards to PV matters.
- Promote the pharmacovigilance within the project/study teams and within the company.
- MD with at least 10 years of experience in Pharmaceutical industry.
- Minimum 5 years of Managerial experience in Pharmacovigilance.
- Proven track record managing service providers such as CROs and working with in-and out-licensees.
- Experienced in writing safety reports, risk management plans and other safety documents.
- Able to work closely with Clinical Development teams.
- Experienced in setting up PV processes and building organization capabilities.
- Excellent knowledge of pharmacovigilance and regulatory procedures (Swiss, Europe and USA).
- Good communication and negotiation skills.
- Ability to work and influence within a matrix organization.
- Attention to details.
Debiopharm can offer you
- An international and highly dynamic environment, with a long term vision.
- The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry.
- The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.
If you fit this profile please send your application using this form.
For more information : www.debiopharm.com
Reporting to the Director Regulatory Affairs, you contribute as project team member to the strategic and operational aspects of regulatory affairs, within a matrix organization.