- Define, set up & implement the business model under the direction of the Multi-Country Safety Head. Set up and ensure an effective oversight and management of the Partner Market Service Providers (PMSP) across the MCO/region including regular meetings with the PSMPs, monitoring compliance with the PV Agreements (PVAs) and maintenance of the PVA.
- Ensure the implementation of PV in assigned territory, acting as the interface between PSPV, the MCSH and the PMSPs. This further includes interactions with Francophone, Anglophone and Portuguese services provides.
- Transversal coordination: Set up and ensures PV training, processes and tools are in place with the PMSPs, ensures that they are compliant with GPV standards and are harmonized across countries. The Partner Market PV Lead shall identify areas of risk and escalate and work with stakeholders to resolve. Promote and deploy initiatives aimed at harmonizing and promoting best practices across PMSPs. In addition, when appropriate, he/she may need to work collaboratively with the Global PSPV SMEs in developing process-related solutions oriented at the PMSPs as well as interacting closely with other GPV functions to contribute to the appropriate management of the Sanofi PV system.
- Is the contact point between PMSPs and the Global teams, and performs other activities which require a coordination role as new process implementation, communication to partners, implementation of additional Risk Minimization Measures and its tracking, contribution to the PSMF, Supports Inspection and Audit activities etc.
- Work collaboratively with other Sanofi functions contributing to the success of the PMSPs collaboration.
- Supports the South Africa affiliate to:
- Ensure that local PV activities relating to assigned responsibilities 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)
- Establish and maintain a robust and efficient local PV system by ensuring the availability and implementation of proper systems/procedures, tools and training.
- Ensures the appropriate management of PV activities associated to clinical trials in sub-Saharan Africa, notably notifications to Health Authorities and oversight of any outsourced activities if applicable.
- 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.
- 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 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.
- 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.
- 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
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.
- Excellent organizational and planning capabilities, and experience in problem-solving
- Strong negotiation skills
- Strong interpersonal skills.
- Strong Leadership competencies
- Team player
- Fluency in English (both oral and written, including technical terminology) and communication skills (oral/written)
- Inter-cultural skills/ability to work across cultures.
- 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.
Education
- MD, Pharmacist, PhD or masters degree in human health sciences
- 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
- Country PV experience is an asset.
- Knowledge of other languages. Fluency in French is advantageous.
- Project management experience.
- 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 wont: 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 dont 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.
Better is out there. Better medications, better outcomes, better science. But progress doesnt 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, lets 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, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
sanofi-aventis IS AN EQUAL OPPORTUNITY EMPLOYER.IF YOU ARE INTERESTED IN APPLYING FOR THIS VACANCY AND YOU ARE CONFIDENT THAT YOU MEET THE CRITERIA AS SET OUT IN THE ADVERTISEMENT PLEASE COMPLETE AN INTERNAL APPLICATION FORM
(Available from HR or your Manager) AND SUBMIT TO THE HUMAN RESOURES DEPARTMENT
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
