PV Specialist - Oncology

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The PV Specialist / Deputy Local Pharmacovigilance Responsible Person is responsible for ensuring that the collection, reporting, handling, oversight and documentation of safety information associated with Servier products are organized and performed in accordance with global Servier requirements and applicable local regulations.

 The role maintains local pharmacovigilance system compliance, ensures inspection readiness, oversees safety risk management activities and acts as the affiliate reference point for pharmacovigilance governance.

Activities & Responsibilities

Case management and safety reporting: Ensure appropriate management of pharmacovigilance cases from all sources, including collection, processing, reporting, follow-up, reconciliation and documentation according to internal procedures and regulatory timelines.

Literature surveillance and regulatory intelligence: Ensure screening of local scientific literature, processing of identified ICSRs, continuous monitoring of local pharmacovigilance legislation, impact assessment and communication of relevant changes to Global Safety.

Risk management, signal detection and safety communication: Maintain oversight of risk management plan implementation, additional risk minimization measures, local signal detection activities, safety queries, safety communications and responses to competent authority requests.

Aggregate reports, labelling and commitments: Provide safety information for aggregate reports, ensure local aggregate report preparation/submission when applicable, contribute to safety label updates and support implementation of local or global commitments.

Studies, programs and business continuity: Ensure appropriate safety reporting processes for interventional studies, non-interventional studies, compassionate use programs and affiliate activities, including out-of-business-hours coverage and continuity of pharmacovigilance operations.

Pharmacovigilance quality system and training: Implement and maintain the local pharmacovigilance quality system, ensure training of relevant affiliate personnel, business partners and service providers, and maintain training compliance metrics.

Interfaces, agreements, archiving, audits and inspections: Oversee key PV interfaces, participate in local pharmacovigilance agreements, ensure compliant archiving of PV documents, act as local contact point for audits/inspections and ensure CAPA implementation within agreed timelines.

• Countries under LPV responsibility: Egypt

Qualifications/skills

Technical skills

• Strong knowledge of pharmacovigilance processes, safety reporting requirements, risk management, signal detection and aggregate report activities.
• Sound understanding of local regulatory requirements, global pharmacovigilance standards, inspection readiness and pharmacovigilance quality systems.
• Ability to coordinate cross-functional safety interfaces and ensure timely reconciliation of potential sources of PV cases.
• Good IT aptitude, including Microsoft Office and relevant internal pharmacovigilance tools.

Behavioural skills

• Demonstrates accountability, rigor, attention to detail and commitment to patient safety and compliance.
• Communicates effectively with internal stakeholders, Global Safety, regulatory partners and external service providers.
• Works collaboratively across affiliate functions while maintaining strong pharmacovigilance governance.
• Shows proactivity, learning agility, ethical conduct and readiness to escalate risks or compliance issues appropriately.

Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognised for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.

At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.