PSPV Country Safety Management L2-1

Sanofi

MAJOR DUTIES & RESPONSIBILITIES:

• Contribute to PV activities for all Sanofi group products, in close collaboration with global and local teams in compliance of local regulatory safety requirements and company policies.
• Support the M-CSH / CSH back-up in maintaining 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.
• Identify issues or dysfunction in the local PV system and escalate areas of risk to the M-CSH or CSH back-up.
• Maintains a local PV system, specifically in one or more of the following areas : ICSR / PSR management, risk management activities, quality system, processes, training, compliance, PV systems, safety data exchange agreements, management of PV requirements in patient support programs, market research, digital projects or any other commercial projects, local safety surveillance, inspection readiness, monitoring of emerging PV regulatory requirements, crisis management.

Support the M-CSH / CSH back-up in maintaining a local PV Operating system

ICSR / PSR management:

• Process domestic drug and medical device individual case safety reports (ICSRs) for marketed and non-marketed product according to PSPV and local requirements
• Handle safety related queries
• Take part in screening and/or appropriate handling of local scientific and medical literature
• Contribute to establish the benefit-risk profile of all Sanofi group products, in close collaboration with corporate and local teams, while maintaining compliance with Corporate and country regulatory safety requirements.
• Handle appropriately local periodic reports, including periodic safety reports (PSRs) and periodic reviews, and contribute together with PSPV and RA departments to the planning for PSRs
• Participate in the 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

Support the M-CSH / CSH back-up in maintaining a local Safety Management system

Risk management activities:

• Participate in 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
• Local safety surveillance,
• Contribute to establishing the benefit-risk profile of all Sanofi group products, in close collaboration with corporate and local teams, while maintaining compliance with Corporate and country regulatory safety requirements.
• Support the GSO in taking part in local sentinel role supporting the global safety signal detection for all products in the country(ies)
• Ensures that any safety-related questions received from local Health Authorities and any local safety issues are raised and managed in timely manner

Support the M-CSH / CSH back-up in maintaining a local PV Quality System and Compliance

• Take part in implementation of processes in compliance with regional/local PV regulations and global Sanofi group procedures and cooperate including monitoring of emerging PV regulatory requirements,
• Participate in monitoring of 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)
• Participate in maintaining of auditable trail of all PV activities performed locally and readily available
• Participate in completion in timely manner audit and inspection observations in close interaction with Global/Local Functions
• Participate in local compliance metrics monitoring, Root Cause Analysis (RCA), Corrective Actions/Preventive Actions (CAPAs) implementation and related tracking activities (ICSRs/ PSRs/HA queries)

Maintain Compliance

Abide by the requirements of the Code of Ethics including but not restricted to maintaining high professional standards of conduct in line with the Company procedure with a duty of care to the reputation of the Company.

Ethical Leadership

• Takes personal accountability to use personal experience and knowledge, as well as the training and tools provided by Sanofi, to maintain a good knowledge and understanding of all ethics and governance relevant to the role (Sanofi Policies and Procedures and any relevant legal requirements) and demonstrate personal leadership in applying these to all work undertaken.
• Escalates any decisions, or seek the support of colleagues or management if personal knowledge and understanding is not at the level required to carry out any part of the role

Knowledge And Skills:

• Strong knowledge and expertise in international and national (Pharmacovigilance) regulations as well as industry standards
• Sufficient ability to interpret clinical data including safety data.
• Ability to work in international and transversal teams. Action-oriented, able to work with constant short deadlines Able to manage projects
• Skilled with computer applications Communication skills
• Organization and priority setting skills
• 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

Formal Education and Experience Required:

Education

• Medical Doctor, Pharmacy Doctor, Pharmacist or Physician with at least 3 years pharmacovigilance/clinical development experience.
• Knowledge of required standards for high quality safety relevant documents, e.g. ICSR, PSR, RMP, PSP, MR, etc.

Experience

• Appropriate experience with specific PV activity if relevant e.g. ICSR, PBRER, RMP, PSP, MR etc.
• Experience with pharmacovigilance systems and safety-related product management in both clinical development and marketed products is highly recommended.