Country Safety Head

Country Safety Head

Sanofi

Gentilly, France

About the opportunity:

Sanofi is looking for the France Country Safety Head (CSH) for our French affiliate. In this role, you will be in charge of the Pharmacovigilance Excellence and the Safety teams under the management of the GPV EU Head and the QPPV in close collaboration with the Global PV Business Units teams while implementing a very efficient collaboration with the French Health Authorities.

This is a highly visible position; you will be a permanent member of the Country Council and play an important role of shaping the future of the team and PV activities in France.

About growing with us:

In this role, you will:

  • Ensure compliance with the Global Pharmacovigilance (GPV policies and with French Pharmacovigilance (PV) regulations;
  • Be responsible for organizing, implementing and maintaining a local PV system. You will ensure that local PV unit resources, training, systems/procedures and tools, are available and implemented;
  • Ensure full compliance with local and global safety regulations as required by French and European health authorities (HA) for local case intake processing and reporting;
  • Be 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;
  • Serve as the local PV contact for the authorities, accountable for PV inspections;
  • Be nominated as local Qualified Person for Pharmacovigilance (QPPV) in delegation of the Responsible Pharmacist “Pharmacien Responsable”;
  • Support local safety surveillance activities by looking at and monitoring event frequencies/severity at local level;
  • Act as the project coordinator for risk management and for risk minimization activities in coordination with other relevant stakeholders;
  • Broker the adaptation of the company Core Risk management strategy of the country taking into account the local country label, national requirements, medical practices, and other factors (e.g. local risk factors such as off label use, population factors);
  • Build close links with the in-country partner functions, including but not limited to Commercial, Medical, Regulatory, Quality, Legal, BU functions, and Country Chair;
  • Lead the team (approx. 20 people), manages budget and resources.

About you:

Education:

  • Medical Doctor (MD) or Pharm D (Doctor of Pharmacy).

Experience:

  • 5 to 8 years of experience in the Pharmaceutical Industry with extensive PV/Drug Safety work and experience with Regulatory Agency interactions;
  • Experience with PV systems and safety-related product management in both clinical development and marketed products.

Competencies:

  • Strong knowledge and Expertise in France (Pharmacovigilance) regulations and international regulations as well as industry standards;
  • Sufficient clinical interpretational skills based on limited information provided along with understanding of medical terminology;
  • Interpersonal skills of diplomacy and team player dynamics; knowledge and respect for cultural differences; professionalism and arbitration 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;
  • Fluency in French and English;
  • Ability to work in international and complex environment with transversal teams;
  • Proven ability to lead a team in a challenging environment through an engaging and motivating leadership style.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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