PrimeVigilance has announced an opportunity for a PV Officer – Medical Device & Product Experience in Pune, Maharashtra. This full-time, hybrid pharmacovigilance position is part of the ICSR Management department and focuses on Individual Case Safety Report processing, medical device vigilance, SAE/SUSAR management, case quality review, reconciliation and regulatory compliance.
The PrimeVigilance PV Officer job in Pune is suitable for candidates with a life science, pharmacy, nursing or other healthcare-related background who already have relevant experience in pharmacovigilance and medical device vigilance.
Candidates should have working knowledge of EU MDR 2017/745, medical device incident reporting, safety databases, ICSR processing and regulatory reporting requirements.
About PrimeVigilance
PrimeVigilance is a global pharmacovigilance specialist and part of the Ergomed Group. The organization provides pharmacovigilance and patient-safety services across different stages of medicine development and post-marketing surveillance.
Its teams support pharmaceutical and healthcare clients with safety-data management, regulatory compliance and interpretation of safety information to help protect patients.
Key Responsibilities
As a PV Officer at PrimeVigilance, the selected candidate will support ICSR and medical device safety activities according to applicable regulations, company procedures and client-specific requirements.
Key responsibilities include:
- Process Individual Case Safety Reports (ICSRs) received from different sources within defined regulatory and client timelines.
- Perform intake, triage, assessment, data entry, follow-up and processing of medical device safety and incident reports.
- Conduct follow-up activities for pharmacovigilance cases to obtain relevant missing information.
- Support SAE and SUSAR management, including unblinding, clinical trial reconciliation, protocol review and Safety Management Plan review.
- Perform clinical and partner reconciliation activities.
- Conduct quality review and QC of medical device cases for completeness, accuracy, consistency, appropriate coding and SOP compliance.
- Evaluate information related to medical device seriousness, reportability and device-relatedness.
- Support compliance with applicable medical device regulatory reporting requirements.
- Handle Product Quality Complaints and coordinate with Quality Assurance teams where required.
- Perform MedDRA and WHO coding.
- Generate database outputs and information required for periodic or monthly client reporting.
- Maintain appropriate personal-data protection and confidentiality requirements.
- Support workflow and resource management activities.
- Mentor and train new or junior colleagues within the department.
Qualification and Eligibility
Candidates interested in this PrimeVigilance pharmacovigilance job should have a relevant life science or healthcare educational background.
Suitable qualifications may include:
Life Science Graduate / B.Pharm / M.Pharm / Pharm.D / Nursing / B.Sc or M.Sc Life Sciences / Biotechnology / Microbiology / Biochemistry / Clinical Research or another relevant healthcare qualification.
The official job description specifically requires a life science graduate, pharmacy, nursing or other healthcare-related qualification, or relevant pharmacovigilance experience.
Educational eligibility may ultimately depend on PrimeVigilance’s screening and selection criteria.
Experience Required
This is not specifically advertised as a fresher position.
Candidates should have:
- Demonstrated experience in pharmacovigilance.
- Relevant experience in medical device vigilance.
- Experience handling global and/or European medical device safety cases.
- Experience working with safety databases.
- Ability to review cases and identify data discrepancies.
- Understanding of medical device safety and regulatory compliance requirements.
The employer has not specified an exact minimum number of years of experience in the provided job description.
Key Skills Required
Candidates should have knowledge or experience in:
- ICSR Processing
- Medical Device Vigilance
- EU MDR 2017/745
- Medical Device Incident Reporting
- SAE/SUSAR Management
- Safety Case Processing
- Case Intake & Triage
- Case Follow-up
- Medical Device Case QC
- MedDRA Coding
- WHO Coding
- Safety Databases
- Product Quality Complaints
- Clinical Trial Reconciliation
- Regulatory Reporting
- Pharmacovigilance Compliance
- Data Quality Review
- MS Office
Candidates should also possess excellent written and verbal communication skills, attention to detail, organization, planning, delegation, time management and teamwork skills.
Fluency in spoken and written English is required.
Why This Role Is Important
Medical device vigilance plays an important role in identifying, assessing and reporting safety incidents associated with medical devices.
In this PV Officer position, the successful candidate will work across both traditional pharmacovigilance activities and medical device safety reporting, including case intake, assessment, follow-up, quality review and regulatory compliance.
The combination of ICSR management and medical device vigilance makes this opportunity particularly relevant for pharmacovigilance professionals looking to strengthen their expertise in device safety and EU MDR requirements.
Benefits of Working at PrimeVigilance
According to the job description, employees joining PrimeVigilance and Ergomed Group work within an international environment covering clinical research, pharmacovigilance and quality consulting.
The organization highlights a workplace culture based on:
- Professional growth and development
- Global pharmacovigilance exposure
- Collaborative working
- Flexible working culture
- Quality and patient safety
- Integrity and trust
- Agility and responsiveness
- Inclusion and belonging
- Cross-functional partnerships
The advertised position follows a hybrid work model in Pune.
Estimated Salary
PrimeVigilance has not disclosed a salary range for this vacancy.
For structured-data purposes and based on comparable experienced pharmacovigilance and medical-device-vigilance positions in India, an estimated range of approximately ₹5,00,000–₹9,00,000 per year may be reasonable.
Important: This is an editorial market estimate and is not an official salary disclosed by PrimeVigilance. Actual compensation may differ depending on experience, skills, current compensation, internal salary bands and interview performance.
How to Apply
