Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme. At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.
Post : Country Safety Lead (f/m)
Key accountabilities
In this position you will be in charge of Pharmacovigilance for Switzerland in collaboration with corporate & local health authorities. You will have the following responsibilities:
- Ensure compliance with the Global Pharmacovigilance & Epidemiology (GPE) policies and with local Pharmacovigilance (PV) regulations. Ensure that global Sanofi group procedures are implemented, documented and followed locally. Accountable for keeping Global aware of any future changes in local PV regulations.
- Ensure timely completion of audit and inspection observations in close interaction with Global /Local Functions. Is nominated as local Qualified Person for Pharmacovigilance (QPPV ).
- Ensure full compliance with local and global safety regulations as required by local and regional health authorities (HA). Support local safety surveillance activities by looking at and monitoring event frequencies / severity at local level.
- Is recognized as the key leader for all PV related activities on country level, including case management, compliance, risk management and risk mitigation, patient support programs and market research programs in adherence with HA regulations and corporate policies in order to ensure safe and appropriate use of sanofi products on the market in the country (ies).
- Build close links with the in-country partner functions, including but not limited to Commercial, Medical, Regulatory, Quality, Legal, BU functions and Country Chair.
- Manage budget and resources (Team of 2 persons)
- The Country Safety Lead is a permanent member of the country council.
Candidate Profile
- Medical doctor, Pharmacist, Doctor of Pharmacy or educational background in Health Sciences with at least 10 years of experience in Pharmacovigilance.
- Good knowledge of Swiss pharmacovigilance legal environment and international regulations.
- Sufficient clinical interpretational skills based on limited information provided along with understanding of medical terminology.
- Experience working within an international company with a complex organizational environment with pharmacovigilance systems and safety related product management.
- Demonstrate problem solving skills, sense of urgency, especially with respect to enforcing safety rules and global procedures as described in Quality Documents, Operational Manuals and Guidance documents. Capacity to work under pressure.
- Proven ability to lead a team in a challenging environment with sometimes conflicting priorities trough an engaging and motivating leadership style.
- Ability to work in German, French and English.
Additional Information:
Experience: 10 years
Location: Vernier, Baar
Education: Medical doctor, Pharmacist, Doctor of Pharmacy
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Safety Lead
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