Senior Pharmacovigilance (PV) Specialist

Acino Pharma

This position is based in Cairo, Egypt and will report directly to the Pharmacovigilance Head META. The role will be responsible for monitoring, assessing, and reporting the safety of pharmaceutical products, ensuring compliance with global regulatory standards.

Your Responsibilities will be:

Safety Data Exchange Agreements (SDEAs)

• Draft, negotiate, and maintain SDEAs with business partners in META region in compliance with corporate and regulatory requirements.
• Ensure timely execution and periodic review of SDEAs, including reconciliation of safety responsibilities and timelines in coordination with GPV.
• Track SDEA obligations and ensure alignment with internal SOPs and global PV standards.
• Coordinate with legal, regulatory, and compliance teams to ensure contract integrity and audit readiness.

Business Partner (BP) Communication

• Act as the primary PV liaison for regional business partners, distributors, and license holders.
• Ensure timely exchange of safety data and compliance with agreed pharmacovigilance obligations.
• Provide PV Onboarding/Refreshing training to BPs in alignment with global procedures.
• Monitor BP compliance metrics and escalate deviations or risks as needed.

Management of Internal CAPAs and deviations

• Managing internal CAPAs and deviations in TrackWise, documenting quality events, assigning corrective actions, tracking progress, and ensuring compliance through automated workflows and audit-ready records.

Global PSMF Maintenance

• Ensure Global PSMF remains accurate, up-to-date, and compliant with regulatory requirements across all applicable regions.
• Maintain the regional annexes of the Global Pharmacovigilance System Master File (PSMF)

Assigned tasks from GPV responsibilities

• Conduct regular screening of scientific and medical literature to identify potential adverse events and ensure compliance with global pharmacovigilance requirements
• Prepare and review periodic safety update reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and other aggregate safety reports to summarize the benefit-risk profile of medicinal products.
• Develop and maintain risk management plans (RMPs) to proactively identify, assess, and mitigate safety risks associated with pharmaceutical products.
• Perform signal detection and evaluation activities to identify new safety concerns and trends from various data sources
• Performs other tasks under direction of Director PV Operations if requested.

SOPs management

• Oversee the development, implementation, and periodic review of pharmacovigilance Standard Operating Procedures (SOPs) to ensure regulatory compliance, operational consistency, and alignment with global quality standards.