Manager - Medical Affairs (Pharmacovigilance)

About the role

Julphar is looking for a Manager - Medical Affairs to act as the Subject Matter Expert in Pharmacovigilance. The role covers oversight of pharmacovigilance activities, liaison with regulators, safety reporting, training and vendor management, and supports the departmental management team.

Key responsibilities

• Serve as the Subject Matter Expert in Pharmacovigilance and liaise with legal and regulatory health authorities, facilitating audits and inspections
• Deliver training and presentations to highly technical and scientific audiences
• Oversee pharmacovigilance activities in countries where Julphar has scientific offices, with Local Safety Responsible (LSR) personnel
• Prepare, review and analyze Pharmacovigilance SOPs, and participate in regional Health Authority audits
• Manage Safety Data Exchange Agreements (SDEAs) and oversee Risk Management Plans (RMPs) for Julphar products
• Perform MedDRA coding for Individual Case Safety Reports (ICSRs) and manage end-to-end vendor services
• Coordinate and monitor local and global literature surveillance, and oversee the intake, processing and submission of ICSRs
• Train university students and Julphar staff on pharmacovigilance, and define an efficient organizational structure for the function
• Review compliance with operational and administrative policies across the division

Required profile

• Master's degree in pharmacy or a closely related discipline
• Minimum of 10 years of progressive experience in Pharmacovigilance
• Prior experience in a similar role is essential
• Valid MOHAP license as a Qualified Person Responsible for Pharmacovigilance (QPPV)
• Demonstrated experience developing and delivering pharmacovigilance training programs

Required skills

• Hands-on experience in regulatory audit inspections (US-FDA, EMEA, MHRA) in the context of Pharmacovigilance compliance
• MedDRA coding
• Strong communication skills with technical audiences and stakeholder management