Job Description

Roles & Responsibilities

Job Description

Location: United Arab Emirates, Dubai

About The Job

As Pharmacovigilance Associate VIE within our Pharmacovigilance & Safety team, you ll be in charge of assigned operational Pharmacovigilance tasks within the greater gulf countries. You will support the Greater Gulf PV team 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), as well as establish and maintain a robust and efficient local PV system by ensuring the availability and implementation of proper systems/procedures, tools and training.

Main Responsibilities

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.
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.
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.
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.

Experience

About you

Experience with pharmacovigilance systems and safety-related product management in both clinical development and marketed products is highly appreciated.
A minimum of experience in either pharmacovigilance or regulatory or quality or medical or clinical development is necessary.

Soft And Technical Skills

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, capacity to work under pressure.
Ability to work in international and transversal teams.
Sufficient knowledge in international and national (Pharmacovigilance) regulations as well as industry standards.
Sufficient ability to interpret clinical data including safety data.

Education

Medical Doctor, Pharmacist, Pharm D, Veterinary Doctor, Health Sciences PhD, MPH or Master s degree in a similar field.

Languages

Proficiency in English (verbal and written) to accurately communicate PV information.
Arabic knowledge would be a plus.

Pharmacovigilance Associate - VIE Contract
Sanofi

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