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.

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.