Head of Pharmacovigilance (m/f), Loos / La Garenne

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Tasks

• Lead and manage the French PV team and provides medical guidance in pharmacovigilance matters.
• As a member of the French Medical Leadership Team, be responsible for providing strategic and proactive input to the Medical, Pharmaceutical and BHC Management teams on all PV-related issues including issue preparedness and issue management.
• Be responsible for managing local safety issues and crisis management in collaboration with the local organization and relevant Global functions.
• Ensure the maintenance of the company’s compliance with respect to laws, regulations and guidance associated with the licensure of Bayer medicinal products with respect to patient safety and the correct implementation and observation of all safety related Standard Operating Procedures (SOPs), Working Procedures (WPs) and Operational Instructions (OIs) of BHC PH, BHC CH and BHC radiology referring to local safety ctivities.
• Ensure the collection, review, processing and distribution of adverse event information on a country level regarding the BHC PH, BHC CC and BHC radiology products in all therapeutic areas; Guides submission of individual case safety reports to the ANSM according to the local regulations.
• Be responsible for the detection and escalation of local safety observations, review of local relevant medical literature according with the PV standard operations and procedures.
• Be responsible for education and training within the local organization; documentation of topics addressed during the training and of participants in the training.
• Be responsible for ensuring that the PV components of all domestic study protocols and informed consents are reviewed and are compliant with the GPV standards and the protocol template.
• Ensure that Pharmacovigilance principles are applied in the interaction with patients for all local patient support programs and other undertakings of the local organization with potential consequences on PV obligations (e.g. market research, Active-Online-Listening) in coordination with the Medical Gouvernance Unit.
• Lead the local Safety Management Team (SMT) and liaise with the relevant expert functions in the local Safety RMP development and intervention implementation activities.
• Build a trustful and appropriate interaction with health authorities on safety and benefit-risk related matters (in alignment with Regulatory Affairs)

Who you are

• Graduated with a Medical Doctorate or equivalent university degree in pharmacy, pharmacology, chemistry or the biological sciences, incl. Ph.D, you own at least a minimum of 5-8 years’ experience in a (global) healthcare organization, esp. Clinical Development and/or Medical Affairs and/or Pharmacovigilance.
• Preferably, you have experience in dealing with relevant safety issues, involving authorities and media, as well in developing local risk management strategies.

You show the following skills

• Ability to think and act strategically
• Demonstrated leadership skills including the ability to lead, coach, mentor and develop high performing teams
• Strong ability to function effectively and successfully in a complex global and multicultural organization
• Highly effective communicator with strong influencing ability and communication skills
• Strong organizational and process management skills
• Strong financial reporting experience and skills and understanding of business systems
• Ability to take personal responsibility and accountability
• Fluency in French and English (written and verbal communication skills).
• Collaboration, team-oriented, flexibility