Pharmacovigilance Specialist CLIN BIOSCIENCES

About CLIN BIOSCIENCES

Job Description

Pharmacovigilance Specialist is primarily responsible for ensuring the safety of medicinal products by monitoring and evaluating adverse drug reactions (ADRs). Their role includes receiving, documenting, and reporting ADRs to the Ministry of Health and Prevention (MoHAP) within specified timelines. . They also maintain the company's Pharmacovigilance System Master File (PSMF) and ensure compliance with all relevant UAE regulations. 

• Key Responsibilities:
  • Adverse Event Reporting: Receiving, assessing, and documenting adverse event (AE) reports and product complaints from various sources (healthcare professionals, patients, company staff).   
  • Regulatory Compliance: Ensuring adherence to all UAE pharmacovigilance regulations and internal standard operating procedures (SOPs).   
  • PSMF Management: Maintaining an accurate and compliant Pharmacovigilance System Master File (PSMF).   
  • Communication & Collaboration: Acting as the primary point of contact for all PV-related communications and inspections by MoHAP. Collaborating with internal teams (Regulatory Affairs, QA, Medical Affairs) on safety-related matters.   
  • Signal Detection & Risk Management: Conducting safety monitoring through literature reviews and signal detection activities. 

Qualifications

• Bachelor's degree in a related field, such as pharmacy, nursing, or biology
• 1-3 years of experience in pharmacovigilance or regulatory affairs is generally expected. Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team

Interested to apply can share CV or call/whatsapp to 9342735755