Our Team:

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.

The Country Safety Head back-up supports 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.

ABOUT THE JOB:

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
• Operates as Local Safety Officer (LSO) by managing medical safety of assigned local products under the oversight of the Regions Medical Safety Head
• Acts as Local Safety Officer (LSO) back-up and as such manage, in absence of LSO, the medical safety of assigned GPV local products with under the supervision of the Regions Medical Safety Head (RMSH).
• 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)

Local, Region and Global Partnership

Local:

• In collaboration with the CSH, maintain robust collaboration/interaction with the in-country partner functions, to carry out and monitor local PV activities, in compliance with PV regulatory requirements and company procedures/guidelines, and particularly
• Secure with Medical Information, Clinical Study Unit, Quality and Marketing and local third party (e.g. CRO, vendors) the detection and transmission to PV unit of incoming PV data in timely manner
• Contribute to the development of local implementation plan of additional Risk Minimization Measures (aRMMs) and enable its implementation by working cross-functionally with Country GBU Medical Head (or delegate), the Country Regulatory Manager and other appropriate functions

Region/Global:

• Identify issues or dysfunction in the assigned country(ies) and escalate to CSH, and in absence of CSH, to Multi-Country Safety Head / Region PV Head and/or directly to the QPPV
• Interact closely with Regions Governance Team
• In case of PV outsourcing activities, collaborate with Regions Resources & Budget Lead in Global PV management office to implement the best outsourced capabilities
• Interact with the Global Safety Officers (GSO) for any questions related to the safety profile of Sanofi product originating from HA or any other sources
• Collaborate with other PSPV unit such as PV Operations Team, PVA Team, etc. to contribute to the appropriate management of Local PV system

Supports the CSH in the maintenance of local PV Quality system:

• Establish and implement processes in compliance with regional/local PV regulations and global Sanofi group procedures and cooperate with the Country Quality Head (CQH) to document them in local Quality Documents as appropriate
• Develop and maintain the the local Pharmacovigilance System File (LPSF) or the local Pharmacovigilance System Description (LPSD) in accordance with the global standards and local legislation
• Ensure that education and training on PV and relevant safety topics within the local organization are performed including the documentation of attendees and topics covered (i.e. training of service providers and manufacturing sites)
• Manage local compliance metrics generation, Root Cause Analysis (RCA), Corrective Actions/Preventive Actions (CAPAs) implementation and related tracking activities
• Warrant inspection readiness of the local PV system (auditable trail of all PV activities performed locally is maintained and readily available) with key stakeholders (i.e. Quality, Medical and Regulatory)
• Complete in timely manner audit and inspection observations CAPAs in close interaction with Global/Local Functions
• Responsible of the oversight of its local PV activities and providing this oversight to the Region PV Head

Supports the CSH in the maintenance of PV Operating & Safety Management:

In compliance with PV regulatory requirements and company procedures/guidelines,

• Monitor continuously in-coming communication to ensure the detection and appropriate management of in-coming PV data (ICSRs and other safety related information) to report them in timely manner to PSPV/Global PV entities and external stakeholders, such as HAs or partners
• Handle appropriately local periodic safety reports, including periodic safety reports (PSRs) and periodic reviews, and contribute together with PSPV, CSU and RA departments to the planning for PSRs
• Ensure appropriate screening local scientific/medical literature and process the relevant abstract/articles accordingly
• Ensure appropriate implementation and monitoring of PV requirements for global, regional and local programs (e.g. Patient Program, Market Research, Managed Access Program...), and company sponsored digital media
• Screen and analyze national regulations, and forward any future/new/updated PV regulation (draft or final) to PSPV via Regulatory Intelligence unit and Region PV Head
• Participate in the local business continuity plan and after hours’ emergency calls process
• Ensure accurate local implementation of global Safety Data Exchange Agreements (SDEAs), when applicable
• Secure that for all local Business Partner agreements requiring safety provisions, a local SDEA or PV clause is set-up, implemented and maintained as appropriate
• In case of local product in-licensing or local company acquisition: participate, in close collaboration with PSPV, in the due diligence and integration process
• Support the GSO with local safety surveillance activities:  acts as local sentinel supporting the global safety signal detection for all products in the country(ies)
• Handle/escalate product safety alerts in timely manner
• Contribute to the development of local RMP, when applicable, with the support and validation of the Risk Management Expert
• Contribute to the preparation and local implementation of additional Risk Minimization Measures (aRMMs) in collaboration with other functions (Regulatory Affairs, Medical), including tracking in appropriate tool
• Ensure that PV unit is involved in reviewing relevant safety sections of local documents, owned by other affiliates entities, such as labeling, contracts with third parties and local study protocols
• Depending on outsourcing status of above activities, adjust and execute his/her responsibilities, including his/her operational oversight,
• In case of local outsourcing of PV activities to third parties (i.e. vendors/service providers/CROs), manage contract/work order with local service provider, monitor the appropriate execution of outsourced activities and take the appropriate measures in case of deviations

Medical safety management of PSPV local products (LocalSafety Officer role)/(in absence of Local Safety Officer):

• Responsible of the safety surveillance of assigned PSPV local products in compliance with local regulations and Sanofi group procedures. This includes (but not limited to):
• Handling responses to Health Authorities requests,
• Development of periodic safety reports,
• Management of safety signal (detection including literature screening, validation, analysis),
• Development of risk management plans,
• Labelling updates,
• Health hazard evaluations,
• Local studies documents…
• Work in close collaboration with RMSH to ensure appropriate assessment of safety information related to PSPV local products

Education:

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

Experience:

• 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

PLAY TO WIN BEHAVIORS

• Push to go beyond the level we have operated until now:
  constantly challenge the status quo focusing on the priorities that will deliver the best outcomes and letting go what won’t: be intolerant to mediocracy, believe we can and must do better and aim at higher but never at the expenses of our values and judgment.
• Put the interest of the organization ahead of own of those of his her team:
  consider both short- and long-term impact of decisions; puts collective and global goals above individual or local goals; share resources and capabilities with those with the greatest need and impact; enable decision making at appropriate level.
• Act in the interest of our patients and customers:
  actively engage with customers to know their current and future needs; brings an external perspective into decisions.
• Take action and don’t wait to be told what to do:
  take smart and informed best bets with the information at hand and anticipate the consequences of her/his actions; use personal judgement and others’ advice to make bold and impactful decisions which move us forward.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, gender identity or Veteran status.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Sanofi IS AN EQUAL OPPORTUNITY EMPLOYER If you are interested in applying for this vacancy and you are confident that you meet the criteria set out in the advertisement kindly click on the link below.
https://sanofi.wd3.myworkdayjobs.com/SanofiCareers
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