Senior Pharmacovigilance & Medical Affairs Leader

Julphar

Ras Al Khaimah

On-site

AED 350,000 - 750,000

Full time

8 days ago

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Job summary

Julphar is seeking a Senior Pharmacovigilance Specialist to serve as the Subject Matter Expert in pharmacovigilance. You will liaise with regulatory authorities, lead audits, and deliver technical trainings to audiences across regions.

The role requires a Master’s in Pharmacy, 10+ years PV experience, and a valid MOHAP QPPV license. You will oversee PV activities, SOPs, SDEAs, and RMPs, ensuring compliance and high-quality safety data handling across Julphar offices.

Qualifications

  • Must hold a Master’s degree in pharmacy or closely related discipline.
  • Minimum of 10 years of progressive experience in Pharmacovigilance.
  • Valid MOHAP license as QPPV required.
  • Experience developing and delivering PV training programs.
  • Strong ability to communicate complex scientific concepts to technical audiences.

Responsibilities

  • Serve as SME in Pharmacovigilance.
  • Liaise with legal/regulatory health authorities for audits and inspections.
  • Deliver training and presentations to technical audiences.
  • Oversee PV activities in countries with Local Safety Responsible personnel.
  • Support Director with departmental tasks.
  • Prepare, review, and analyze PV SOPs.
  • Participate in regional Health Authority audits.
  • Manage Safety Data Exchange Agreements (SDEAs).
  • Oversee Risk Management Plans (RMPs) and reactive compliance.
  • Perform MedDRA coding for ICSRs; manage PV vendors.
  • Coordinate local and global literature surveillance.
  • Oversee intake, processing, and submission of ICSCRs in relevant countries.
  • Conduct PV training for students and Julphar staff.
  • Define org structure for PV efficiency and communication.
  • Review compliance with PV policies and procedures.

Skills

Leadership
Regulatory compliance
Auditing
Training delivery
Cross-functional collaboration
Communication
Analytical thinking
Decision making under pressure
Problem solving

Education

Master’s degree in Pharmacy

Tools

MedDRA coding

Job description

Julphar is seeking a Senior Pharmacovigilance Specialist to serve as the Subject Matter Expert in pharmacovigilance. You will liaise with regulatory authorities, lead audits, and deliver technical trainings to audiences across regions.

The role requires a Master’s in Pharmacy, 10+ years PV experience, and a valid MOHAP QPPV license. You will oversee PV activities, SOPs, SDEAs, and RMPs, ensuring compliance and high-quality safety data handling across Julphar offices.

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