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
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 Regula
tory Agency interactions
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