Pharmacovigilance Specialist and Country Safety Head Back-up

The PV Specialist and Country Safety Head (CSH) back-up:

• Is in charge of the operational PV tasks within the Levant countries including: Lebanon, Jordan, Iraq, Palestine & Syria, in alignment with the CSH strategy
• 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 to:
• Ensure that local PV activities are performed in compliance with the GPV 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

MAJOR DUTIES & RESPONSIBILITIES:
Serves as the CSH back-up for the products of all applicable Sanofi entities in the Levant countries.

• Replaces the CSH in most of their tasks when they are out of the office, including acting as local PV contact for the authorities and being accountable for PV inspections
• 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

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 CQH to document them in local Quality Documents as appropriate
• Develop and maintain the local PV System Master File in accordance with the global standards
• 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 through completion of periodic reports (e.g. PV Activity Report) and providing this oversight to the Region PV Head and GPV SMEs

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 safety related information) to report them in timely manner to GPV/Global PV entities and external stakeholders, such as HAs or partners
• Handle appropriately local periodic reports, including periodic safety reports (PSRs) and periodic reviews, and contribute together with GPV, CSU and RA departments to the planning for PSRs
• Ensure appropriate screening local scientific/medical literature and forward the relevant abstract/articles to GPV
• Ensure appropriate implementation and monitoring of PV requirements for global, regional and local programs (e.g. Patient Program, Market Research, Managed Access Program…), and company sponsored digital media
• Screen and analyze national regulations, and forward any future/new/updated PV regulation (draft or final) to GPV via Regulatory Intelligence unit and Region PV Head
• Participate in the local business continuity plan and after hours’ emergency calls process
• Ensure accurate local implementation of global Safety Data Exchange Agreements (SDEAs), when applicable
• Secure that for all local Business Partner agreements requiring safety provisions, a local SDEA or PV Clause is set-up, implemented and maintained as appropriate
• Support the GSO with local safety surveillance activities:
• Acts as local sentinel supporting the global safety signal detection for all products in the levant countries
• Ensures that any safety-related questions received from local Health Authorities and any local safety issues are raised and managed in timely manner
• Handle/escalate product safety alerts in timely manner
• Contribute to the preparation and local implementation of additional Risk Minimization Measures (aRMMs) in collaboration with other functions (Regulatory Affair, Medical), including tracking in appropriate tool
• In case of local outsourcing of PV activities to third parties (i.e. vendors/service providers/CROs), manage contract/work order with local service provider, monitor the appropriate execution of outsourced activities and take the appropriate measures in case of deviations.

Knowledge, Skill, Formal Education & Experience Requirements
General

• The CSH back-up must demonstrate sufficient proficiency in English (verbal and written) to accurately communicate PV information outside his/her country

Competencies

• Knowledge in international and national (Pharmacovigilance) regulations as well as industry standards
• 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
• 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
• Ability to work in international and transversal teams.

Education

• Medical Doctor, Pharmacist, Pharm D, Veterinary Doctor, Health Sciences PhD, MPH or master’s degree with two or more years of pharmacovigilance/clinical development experience.
• Other medical scientific university educational background may be considered

Experience

• Experience with pharmacovigilance systems and safety-related product management in both clinical development and marketed products is highly recommended
• A minimum of experience in either pharmacovigilance or regulatory or quality or medical or clinical development is necessary
• Experience on required standards for high quality safety relevant documents, e.g. RMP, PBRER is a plus
• Experience with Regulatory Agency interactions

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