Senior Pharmacovigilance Associate

About the Job 

The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a cutting-age safety group, to enable us to optimize the benefit-risk of our therapies, so we can best serve our patients and consumers.

The PV Regions group is an international, dynamic, and culturally diverse team dedicated to the safety of Sanofi Products in regions/countries.

You will support the Country Safety Head to ensure that local PV activities are performed in compliance with the global/regional/local PV regulations and PSPV QDs to warrant safe and appropriate use of Sanofi products in the assigned country.

Main Responsibilities:

• Replaces the CSH in most of his/her tasks when he/she is out of the office, including acting as local PV contact for the authorities and being accountable for PV inspections.

• Supports the CSH in ensuring that local PV activities are performed in compliance with the PSPV policies, as well as global, regional and local PV regulations to warrant safe and appropriate use of Sanofi products on the market in the assigned country(ies)

• Supports the CSH in ensuring establishment and maintenance of a robust and efficient local PV system by ensuring the availability and implementation of proper systems/procedures, tools and training

• Serves as the local PV contact for the local authorities and acts as the local Responsible Person for Pharmacovigilance (RPP) where applicable per country legislation (this role can be delegated as needed)

About You

• Advanced health care discipline degree (MD, PharmD, PhD, Master of Science, etc.) or equivalent qualification.

• Experience with pharmacovigilance systems and safety-related product management in both clinical development and marketed products is highly recommended.

• A minimum of experience in either pharmacovigilance or regulatory or quality or medical or clinical development is necessary.

• Experience on required standards for high quality safety relevant documents, e.g. RMP, PBRER is a plus.

• Experience with Regulatory Agency interactions.

Soft skills:

• Leadership, able to create networks and to collaborate in an international cross-functional environment

• Interpersonal skills of diplomacy and team player dynamics; knowledge of and respect for cultural differences; professionalism and mediation are important

• Demonstrate problem solving skills, sense of urgency, especially with respect to enforcing safety rules and global procedures as described in QDs, Operational Manuals and Guidance documents. Capacity to work under pressure

• Ability to work in international and transversal teams.

Technical skills:

• Robust knowledge of pharmacovigilance systems & regulations

• Sufficient ability to interpret clinical data including safety data

• Able to evaluate & manage safety signals and define risk management activities

Languages:

• Strong proficient in English and Bahasa Melayu

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Collaborate in a dynamic, fast-paced environment focused on continuous learning and professional development.

• Drive process improvement and innovation in partnership with a motivated and supportive team.