Partner Market PV Lead - SSA at Sanofi

Key Accountabilities:

• Acts as the contact point/interface between PSPV/internal and external stakeholders (i.e Partner market Service Providers)
• Oversees the Service Providers ensuring the maintenance and compliance with the PVAs.  
• Routine management and support of the PV aspects of the Services Providers, including support for audit and inspection.
• Keeps the Multi-Country Safety Head informed on the status of the allocated Partnerships escalating issues as needed.

Coordination role:

• Will participate in the Due diligence activities to select the partners.
• Coordinate the implementation of the PV activities consistently across the regions.
• Will ensure all partners meet KPIs set by PSPV and oversee compliance of partners with applicable regulations. Follows up overall project implementation plan, which involves the transition of PV activities to partners in countries in scope and ensure no noncompliance.
• Ensures the Team members have the comprehensive oversight and management of all the Partnerships for the delegated PV activities including monitoring and enforcement of Partners compliance with the PV Agreements.​
• Is in charge of the monitoring of the budget, in collaboration with the Multi-Country Safety Head.
• Ensuring management, oversight and compliance of PV aspects of clinical trials in all the countries in the Southern Africa MCO including partner markets and South Africa

In the South Africa context:

• In collaboration with the MCSH, 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 relating to PV aspects of clinical trials, patient programs, digital initiatives and market research program
• Ensure appropriate implementation and monitoring of PV requirements for global, regional and local programs (e.g. Patient Support Program, Market Research, Managed Access Program...), and company sponsored digital media.
• Collaborate with other GPV unit such as CAPT Team, etc. to contribute to the appropriate management of Local PV system.
• Establish and implement processes relating to assigned responsibilities in compliance with regional/local PV regulations and global Sanofi group procedures and cooperate with the CQH to document them in local Quality Documents as appropriate.
• Contribute to the local PV System Master File is in accordance with the global standards.
• Manage local compliance metrics generation, Root Cause Analysis (RCA), Corrective Actions/Preventive Actions (CAPAs) implementation and related tracking activities relating to assigned responsibilities.
• Complete in timely manner audit and inspection observations in close interaction with Global/Local Functions relating to assigned responsibilities
• Depending on outsourcing status of above activities, adjust and execute his/her responsibilities, including his/her operational oversight.

Key Internal and External Relationships:

• Internal Relationships: GPV Regions governance, RSHs, QPPV Office, QPPVs, GPV Functions, GPV Regions, GPV Countries, Legal, Business Hubs (PMO) and other stakeholders such as Quality, Medical and Regulatory.
• External relationships: Partners/Service Providers, PV vendors.

Decision Making Authority: 

• Service Provider Pharmacovigilance assessment during due diligence
• Implements approved standards/processes. Must consult deviations from these with the M-CSH.
• Identify PV related risks and communicates impact issues to the M-CSH. Recommend appropriate action plans. 
• Escalates Partners non-compliance with PV regulations and PVAs to the M-CSH
• PV aspects of clinical trials, patient programs, digital initiatives and market research program

Knowledge And Skills:

General

• Working knowledge of international pharmacovigilance requirements, with experience in their practical application.  Compliance focused. 
• Working knowledge of PV Systems, central and local PV operations, PV processes, regulatory compliance, standardization and Pharmacovigilance Agreements in partnerships.
• Knowledge on pharmacovigilance tools and procedures

Education

• MD, Pharmacist, PhD or master’s degree in human health sciences

Experience

• Minimum 4 years’ experience in managing Pharmacovigilance activities in close collaboration with key departments (Medical Affairs, Regulatory, Clinical, Quality Assurance, etc.) or equivalent experience.
• Experience working in multinational environment, across diverse cultures
• Experience working with PV systems in Sub-Sahara African countries
• Experience with PV Agreements and or PV Partnerships and partner relations
• Experience in clinical trials especially PV aspects
• Experience in transversal projects