Johnson & Johnson Careers
EMEA Cross Sector Safety Head, International Pharmacovigilance
Belgium; France; Germany; Spain
Requisition ID: 00001DKX
The EMEA Cross Sector Regional Safety Head, International Pharmacovigilance is the senior safety leader for Pharma and Consumer products for the EMEA Region.
The EMEA Cross Sector Regional Safety Head will:
- Oversee Pharma and Consumer product safety strategy and pharmacovigilance (PV) operations in the region while maintaining highest level of compliance with local regulations and JNJ global policies.
- Be the face of GMO/GMS/OCMS in the region and ensure the strategy is translated and deployed on a regional level.
- Oversee development and implementation of local Risk Management Plans and proactively address any emerging safety concerns. Ensure fulfillment of safety obligations adopted as part of marketing authorizations and other commitments relating to the safe use of the products, including risk minimization measures and post-authorization safety studies requested by a health authority (HA).
- Lead the EMEA Safety organization and build strong networks and collaborations with safety colleagues across all sectors in the region.
- Engage in the review of Post Approval Safety Study protocols conducted locally.
- Drive the Pharma and Consumer safety strategic and operational interests in the region and serve as a key interface between global functions, regional leadership and the local operating companies (LOCs).
- Ensure responsibilities outlined in the Service Level Agreements between Pharma and Consumer safety organizations and the LOCs are mutually fulfilled with respect to product safety accountabilities.
- Oversee Pharma and Consumer medical safety operational and local facing area leaders in the region.
- Contribute to inspection readiness and training related to Pharma and Consumer safety policies and procedures. Participate in product safety issue management with local and regional leaders and serve as a member of the EMEA Medical Affairs Leadership Team and a member of the Board of Directors at Janssen Cilag International, NV and Janssen Biologics, the central Marketing Authorization Holders in the EMEA region.
BA in Technical, Business or Scientific Discipline required. Masters level or advanced degree in medicine, business, human relations, or 9-12 years relevant experience in pharmaceutical, business development or other global regulated industry required in lieu of Masters degree.
International exposure in Pharmacovigilance.
Pharmaceutical Company or other relevant industry experience in the areas of regulatory affairs, quality, pharmacovigilance, business development and related areas required.
Europe/Middle East/Africa, Europe/Middle East/Africa-France, Europe/Middle East/Africa-Germany, Europe/Middle East/Africa-Spain
Janssen Pharmaceutica N.V. (7555)