Specialist, Drug Safety

Job Description

Ready to make a meaningful impact on patient safety across the Middle East? Join our team as a PV (Pharmacovigilance) Specialist and play a key role in pharmacovigilance operations, regulatory compliance, and safeguarding patient well-being across multiple markets.

Key Responsibilities:

• Manage pharmacovigilance intake activities, including reconciliation and follow-up of safety reports.
• Prepare and submit Individual Case Safety Reports (ICSRs) and aggregate safety reports in compliance with local regulations.
• Support pharmacovigilance audits, inspections, and inspection readiness activities.
• Deliver local PV training and promote compliance with pharmacovigilance requirements.
• Escalate safety issues appropriately and maintain accurate PV documentation and archiving.
• Act with a high degree of independence while ensuring adherence to company and regulatory standards.
• Serve as Deputy QPPV for Egypt and provide backup support for PV Responsible Persons in Libya, Sudan, and Yemen when required.
• Contribute to additional PV projects and continuous improvement initiatives under managerial oversight.

Qualifications & Experience:

• Pharmacy or Medical degree.
• Fluency in English and proficiency in Arabic (written and spoken).
• Minimum 1 year of Pharmacovigilance experience within a multinational company.
• Strong knowledge of Egypt Good Pharmacovigilance Practice (GVP) guidelines.
• Previous pharmacovigilance experience in other Middle Eastern countries is a plus.

Required Skills:

Compliance Management, Detail-Oriented, Problem Solving, Teamwork, Time Management, Ways of Working

Preferred Skills:

Customer Follow-Ups, Reconciliations (Inactive)

Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.