PV Associate
Location: Pune, India
Job Type: Full-time
Department: ICSR Management
Company: PrimeVigilance (part of Ergomed Group)
Company Overview
PrimeVigilance, founded in 2008, is a specialized mid-size pharmacovigilance service provider and part of the Ergomed Group. With teams across Europe, North America, and Asia, we deliver high-quality services in:
Medical Information
Pharmacovigilance
Regulatory Affairs
Quality Assurance
We are proud of our consistent global growth, strong partnerships with pharmaceutical and biotechnology companies of all sizes, and expertise across all therapy areas, including medical devices.
At PrimeVigilance, we invest in our people with comprehensive training, career development, and a focus on employee well-being. We believe work-life balance fosters satisfaction, which leads to delivering high-quality client service.
Join us on our journey to make a positive impact on patients’ lives.
Role Overview
As a PV Associate in the ICSR Management team, you will:
Ensure effective cooperation with clients in the area of ICSR Management.
Contribute to the company’s overall goals and objectives.
Work under the supervision of experienced colleagues.
Support various activities undertaken by the project team for clients and the company.
Key Responsibilities
Process Individual Case Safety Reports (ICSRs) from all sources in compliance with:
Regulatory requirements
PrimeVigilance procedures
Client-specific requirements and timelines
Perform ICSR follow-ups.
Manage SAE/SUSAR cases, including unblinding, reconciliation, and protocol/safety plan review.
Conduct reconciliation activities (clinical, partner-related).
Handle Product Quality Complaints (PQCs) and coordinate with Quality Assurance.
Collaborate with Medical Information teams.
Generate and manage database outputs and reports, including monthly reporting to clients.
Qualifications
We are looking for candidates who:
Are interested in pursuing a career in pharmacovigilance.
Are fluent in English (spoken and written).
Have strong IT skills (MS Office).
Are eager to learn and contribute to patient safety.
Possess excellent organizational skills and strong attention to detail.
Demonstrate strong interpersonal and communication skills.
What We Offer
Training and career development opportunities within PrimeVigilance.
Strong focus on personal and professional growth.
A friendly, supportive, and diverse work environment.
Opportunities to collaborate with global colleagues (English is our company language).
Core Values
Our values define how we operate:
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
Diversity & Inclusion
We are committed to diversity, equity, and inclusion, creating a workplace where people from all backgrounds, genders, and ages can thrive. Our human-first approach ensures that our people remain our greatest strength in improving lives worldwide.
✅ We look forward to welcoming your application!
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