Country Safety Specialist

JOB SUMMARY:

The Country Safety Specialist (CSS):

• Work 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 Egypt and Sudan.
• Support the CSH in daily PV activities at country level, including but not limited to case management, local safety surveillance, signal detection, risk management and risk mitigation activities, patient support programs and market research programs.

PRINCIPAL DUTIES AND 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 CSH / CSH back-up / LSO 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 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 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 GPV 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 GPV 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 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/LSO 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 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

Environmental and Safety Leadership

• To care for his/her own safety and wellbeing and the safety of others, and to co-operate with the company to ensure a safe place of work.  To comply with Occupational Health, Safety and Environment (HSE) related processes and procedures, provide his/her team (if has) complying to these issues and audit them. Employees are therefore expected to:
• Support and conform to Company safety rules and procedures to ensure a safe and healthy working environment
• Report any accident, incident or near miss, whether it be of personal injury or property damage
• Assist in the investigation of accidents with the objective of introducing measures to prevent recurrence
• issues by the Company and comply with its requirements. Escalate any doubts or uncertainties to their manager.

III – KNOWLEDGE, SKILL, FORMAL EDUCATION & EXPERIENCE REQUIREMENTS

Knowledge And Skills:

General

• The CSS must demonstrate sufficient proficiency in English (verbal and written) to accurately communicate PV information within and outside his/her country.

Competencies

• Strong knowledge and expertise in international and national (Pharmacovigilance) regulations as well as industry standards
• Sufficient ability to interpret clinical data including safety data.
• Interpersonal skills of diplomacy and team player dynamics; knowledge of and respect for cultural differences; professionalism and mediation are important
• 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
• Resourceful and able to take ownership of areas of responsibility
• 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
• Sufficient clinical interpretational skills based on limited information provided along with a basic understanding of medical terminology and MedDRA coding.

Formal Education And Experience Required:

Education

• Medical Doctor, Pharmacy Doctor, Pharmacist or Physician with at least 3 years pharmacovigilance/clinical development experience.
• At least 5+ total years of experience
• Other medical scientific university educational background may be considered.
• 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.

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 or gender identity.

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