Are you looking to build a meaningful career in the pharmaceutical industry, one that directly contributes to patient safety worldwide? PrimeVigilance, a leading global pharmacovigilance service provider, is hiring a PV Associate (ICSR Management) for its Pune office. This is an exceptional entry-level opportunity for individuals passionate about starting their career in pharmacovigilance.
About PrimeVigilance (Ergomed Group)
PrimeVigilance is a specialised mid-size pharmacovigilance service provider established in 2008. As part of the Ergomed Group, we have achieved consistent global organic growth, with our teams spread across Europe, North America, and Asia.
We are a global leader in providing first-class pharmacovigilance, medical information, regulatory affairs, and quality assurance services to our pharmaceutical and biotechnology partners. We cover all therapy areas, including medical devices, and are known for maintaining long-lasting, collaborative partnerships with our clients.
Our culture is built on investing in our people. We offer an excellent training and development platform, prioritize mental health and well-being, and strongly believe in a healthy work-life balance. We are committed to creating a diverse, equitable, and inclusive workplace where everyone can contribute and grow.
Our Core Values: Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, Collaborative Partnerships.
Job Description: PV Associate – ICSR Management
Department: ICSR Management
Location: Pune, Maharashtra, India
Job Type: Full-time
As a PV Associate, you will be at the heart of ensuring drug safety. You will work under the supervision of experienced colleagues and be responsible for the end-to-end processing of Individual Case Safety Reports (ICSRs). This role is perfect for those excited to learn and make a significant impact in the field of patient safety.
Key Responsibilities:
- Processing ICSRs: Manage and process Individual Case Safety Reports (ICSRs) from all sources in full compliance with global regulations, company procedures, and client-specific requirements within agreed timelines.
- Case Follow-up: Perform necessary follow-up activities to gather additional information for ICSRs.
- Clinical Trial Safety: Support activities related to Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including unblinding and clinical trial reconciliation.
- Reconciliation: Assist in reconciliation activities (clinical and partner reconciliations).
- Product Quality Complaints: Handle product quality complaints and interact with the Quality Assurance department.
- Database Management: Contribute to generating database outputs and reports for monthly client reporting.
- Client Cooperation: Support effective cooperation with clients in all areas of ICSR Management.
Qualifications We Are Looking For
We are seeking enthusiastic and detail-oriented candidates who are eager to begin their pharmacovigilance career.
- A strong interest in pursuing a long-term career in pharmacovigilance and drug safety.
- Excellent fluency in English (both written and verbal).
- Good IT skills and proficiency in MS Office (Word, Excel, Outlook).
- A genuine excitement for learning and contributing to patient safety.
- Outstanding organizational skills with a sharp attention to detail.
- Excellent interpersonal and communication skills.
This is an entry-level position, and comprehensive training will be provided to the right candidate.
What We Offer
Joining PrimeVigilance means investing in your future. We provide:
- Training & Career Development: Extensive internal training and clear paths for professional growth.
- Supportive Environment: A friendly, supportive, and collaborative working environment.
- Global Exposure: The opportunity to work with colleagues from all over the world, with English as the primary company language.
- Work-Life Balance: A strong emphasis on personal well-being and a healthy work-life balance.
- Impactful Work: The chance to contribute to meaningful work that improves patient lives globally.
