Specialist, Drug Safety

Job 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*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.