Country Safety Specialist and Country Safety Head Back-up

3 weeks ago

Johannesburg, South Africa Sanofi Full time

**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 safe

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