PV Officer (Medical Device & Product experience)
Skills
About the role
This is a pharmacovigilance officer role at PrimeVigilance, a global pharmacovigilance specialist, focused on medical device and product safety cases and based in Pune. It suits a life sciences graduate or pharmacovigilance professional with experience in medical device vigilance and case processing. The role covers intake through processing of individual case safety reports and medical device incident reports, with mentoring of junior staff.
What you’ll do
- Process Individual Case Safety Reports from all sources per regulations and client requirements
- Perform ICSR follow-up and SAE/SUSAR management including unblinding and reconciliation
- Intake, triage, assess and process medical device safety and incident reports
- Perform quality review and QC of medical device cases
- Handle product quality complaints and interact with Quality Assurance
- Apply MedDRA and WHO coding
- Mentor and train new and junior employees
What they’re looking for
- Life science, pharmacy, nursing or other healthcare-related qualification, or pharmacovigilance experience
- Demonstrated experience in pharmacovigilance and medical device vigilance
- Working knowledge of EU MDR (2017/745) and medical device vigilance concepts
- Experience with global or European medical device cases and safety databases
- Fluent English, written and spoken
- Advanced MS Office literacy
Questions about this role
Is this role remote?
It's listed as hybrid, based in Pune, India.
What experience is required?
Demonstrated experience in pharmacovigilance and medical device vigilance, plus knowledge of EU MDR (2017/745).
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