Job duties:
- Pharmacovigilance Compliance: Prepare PV files (RMP, ACO, PBRER) and ensure timely reporting of ICSRs, including collection, validation, coding, and submission to PVGA.
- Safety Monitoring: Conduct literature screening, monitor emerging safety issues, and support signal detection and communication to healthcare professionals and patients.
- Medical Education: Participate in delivering medical knowledge training programs for sales teams and provide scientific support for inquiries from healthcare professionals.
- Promotional Material Review: Collaborate with Marketing to deliver promotional content for scientific accuracy and regulatory compliance and provide reliable medical sources to support product strategy.
- Regulatory Documentation: Prepare, update, and review package insert leaflets for healthcare professionals and patients; archive and store related documents in compliance with authority regulations.
- Cross-Functional Coordination: Work closely with Regulatory, Quality, Marketing, and Sales teams to ensure alignment and compliance in all medical and PV activities.
- Audit & SOP Management: Assist in audit preparations, develop and maintain PV SOPs, and support implementation of CAPAs as required.
Qualifications, experience and skills required:
- Physician /Pharmacist ONLY
- 0-3 Years of experience in the same or a relevant field.
- Excellent Medical background.
- Certified PV person. (partial / Full PV courses or PV Diploma / Clinical Pharmacy Diploma)
- English (spoken and written skills).
- Microsoft Office skills and other computer skills, and internet surfing.
- Planning& organizing Skills with very Good presentation skills.
