Pharmacovigilance Specialist At MSD
Job Description
Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.
The PV Specialist reports to the Country PV Lead and is responsible for PV activities as delegated/assigned by their manager which may include but are not limited to:
PV Intake activities (including conducting reconciliation and follow-up), Individual case safety report (ICSR) and aggregate submissions.
Supporting audits and inspections and related readiness activities, authoring local SOPs, local training, escalation of safety issues, and archiving & able to perform these tasks with minimal supervision.
The PV Specialist acts as the deputy QPPV for Egypt and back up for PV responsible person for Libya, Sudan and Yemen.
The PV Specialist may undertake other additional activities including projects with oversight by their manager.
Qualifications and Experience:
Must be holding a Pharmacy or Medical degree.
Fluent in English (written and spoken) while proficient in Arabic local language
Experience at least 1 Year of PV experience in a multinational company
Experience with “Arab guidelines for good pharmacovigilance practice”
Skills:
Strong communication skills
Time Management skills
Collaboration and Partnering
Problem Solving