Specialist, Drug Safety
Description
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
Search Firm Representatives Please Read Carefully
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.
Employee Status:
Regular
Relocation
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Not Applicable
Shift
Valid Driving License
Hazardous Material(s)
Job Posting End Date
10/7/2026