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CHC - Pharmacovigilance Operations Head (H/F)

Plný úvazek
Chilly-Mazarin
Plat: Neuvedeno
Žádná práce na dálku

Sanofi
Sanofi

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About the opportunity

We are looking for our Pharmacovigilance Operations Head withinSanofi Consumer Health Care.

In this role, you will be responsible for all the PV Operations, overseeing global :

  • Case management

  • System support management and data management

  • Periodic reporting management (PSURs, PBRERs, generation of ad hoc data report requests

  • PV operations for medical device

About growing with us:

Your main objective will be to build, manage and ensure compliance of the PV operational platform and globally integrated processes, which will support all PV activities.

You will have to :

  • Systematically ensure PV processes are regulatory compliant, efficient and productive;

  • Define, oversee and manage the sourcing strategy for all operational activities including case management and periodic reporting activities;

  • Implement new operational systems, applications and new technologies to meet company requirements and regulatory obligations;

  • Ensure platform support for all operational pharmacovigilance activities and to interact with all Therapeutic Areas, Clinical Research and Health Authorities on a global basis.

  • Provide, within the group, the Pharmacovigilance data management for the products under development or the marketed ones across all Global Business Units and markets;

  • Ensure and maintain, within the group, the regulatory compliance in terms of Pharmacovigilance, in accordance with the norms and procedures of the Health Authorities on all markets worldwide;

  • Improve and reinforce globally integrated standards, procedures and tools/systems in line with changes in the regulatory environment and best industry practices.  Ensure essential PV foundational supported needed to enable timely and proactive signal detection and risk management;

  • Build synergy and partnerships with other global PV departments, PV teams within the affiliates/regions and key R&D groups (in particular, Clinical Operations), as well as with the external partners;

  • Supervise, in close collaboration with the GBU PV groups and Global Safety Sciences, the preparation and validation of the periodic reports send to the Health authorities (ICSRs, PSURs, ad hoc studies/reports) in accordance with the legislation;

About you :

  • You are a senior experienced international leader within an R&D pharmaceutical organization, ideally, bilingual English/French with an extensive international experience;

  • Scientific or engineer educational background: A PhD or an MBA would be a plus.

  • Minimum 10 years’ experience in the pharmaceutical industry; and a combined career path in R&D and/or medical affairs.

  • You have ideally undertaken a wide range of responsibilities and held down various functions within an R&D and CMO organizations, including responsibilities in Pharmacovigilance and/or Regulatory affairs and/or Clinical Operations.

  • You have demonstrated a strong interest and ability to develop and transform organizations and business process, including re-engineering of workflows and IT systems; with strong project management experience; ideally including having led outsourcing initiatives.

  • Successfully managed and developed large and multicultural teams in R&D/Medical Affairs, within international organizations.

About Sanofi CHC Purpose and Aspiration

  • At Sanofi CHC, we have one shared purpose - we work passionately, every day, to ‘serve healthier, fuller lives. Our marketing philosophy is driven by this purpose and everything we do is centred around people – our consumers, our customers, healthcare professionals, and our employees – across the world.

  • We are building brands that serve 1bn consumers worldwide, so that they can live healthier, fuller lives. In order to do this better than anybody else, we aspire to become the most consumer-centric Consumer Healthcare company. We want to be market shapers and achieve category leadership in the categories that we play in - delivered through strong global-local partnership. We are a people first business, placing consumers at the heart of everything we do through uncovering and activating deep consumer and shopper insights, for example.

  • As a top 3 global CHC player, we want to raise the bar in terms of our strategic and operational capabilities to enable sustainable, above-market growth. In order to achieve this, we need strong talents that will help us shape the future of CHC while sharing our core values of courage, teamwork, respect and integrity.

  • We have recently announced an exciting 18-24 month journey to create a fully standalone CHC business (separating the Business Unit from our Pharma company heritage, processes etc), as we target to create the best FAST MOVING CONSUMER HEALTH company, which will require us to retain, attract and grow the best leaders in our industry.

Own your future and make your move:

Contract : Permanent ContractTo be Filled : As soon as possible

Inspire your Journey: what Sanofi can offer you

  • An international work environment, in which you can develop your talent and realize ideas and innovations

  • You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully.

  • As a globally successful and constantly growing company, Sanofi provides international career paths as well.

Your applicationAre you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a team to serve healthier, fuller lives ? Then send us your online application including cover letter and CV in English

This is our Sanofi. Discover yours: https://www.sanofi.com/en/careers/

#LI-FR

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