Job Ref. ID:
Assistant Manager - Pharmacovigilance
UNITED ARAB EMIRATES
UAE (RAK head office)
Medical Affairs - Assistant Manager - Pharmacovigilance
Full Time Employment (Un-limited Contract)
As Assistant Manager - Medical Affairs Department, you will be reporting directly to the Medical Affairs Director for your all assigned activities. You should have department level influence and to lead a team of Pharmacovigilance Specialists and Local Safety Responsible in UAE and other countries. You have to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required Pharmacovigilance legislation. You have to represent Julphar in scientific communities and liaison with Health Authorities.
Key responsibilities & Accountability:
To coordinate directly with Ministry of Health (MOH) of various Middle East - North Africa countries for Pharmacovigilance requirement. To be able to prepare for health authority audit and presentation. Safety Data Exchange Agreement writing/reviewing along with Company Legal Department. Developing in house Pharmacovigilance Team. Setting up Pharmacovigilance Plan for next three years for the organziation. To be able to draft SOPs for different process in Pharmacovigilance and its training. Vendor allocation and management for electronic database and reporting for pharmacovigilance. Maintenance of PSMF and its approval from various MENA Health Authorities. Aggregate report writing (PSUR, RMP, ACO, etc.) as required by various Health Authorities. ICSR processing in Pharmacovigilance Database. Overall experience for managing a Pharmacovigilance system for a mid-size pharmaceutical organization.
Bachelor's / Master's Degree in Pharmacy or any equivalence.
Minimum of years' experience in Pharmacovigilance with emphasis of in MENA region is preferred. MOH UAE approved.
- Specialized Knowledge and Skills:
Excellent English language is required with Arabic Language preferred but not mandatory. Excellent experience in working with Microsoft Office.
AccountabilityAnalytical ThinkingBuilding TrustCommunicating in WritingCommunicating OrallyContinual LearningEstablishing FocusFlexibilityGetting ResultsInitiativeInnovationInterpersonal Skills
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