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

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

https://jordan.tanqeeb.com/ar/jobs-in-jordan/all/jobs/019399956.html