Job Opportunity: Pharmacovigilance Associate – Pune
Summary:
Are you a passionate and detail-oriented professional with experience in pharmacovigilance? We are seeking highly motivated Pharmacovigilance Associates to join our growing safety team in Pune. This is an exciting opportunity to contribute to drug safety, case processing, and regulatory compliance within a dynamic and supportive environment. If you have a strong understanding of ICSR, a background in life sciences, and are eager to work in a collaborative, fast-paced setting, we encourage you to apply! This is a full-time, on-site role requiring rotational shifts and relocation to Pune.
About the Role:
As a Pharmacovigilance Associate, you will be an integral part of our team, responsible for ensuring the safety of our products and contributing to the well-being of patients worldwide. You will be involved in all aspects of Individual Case Safety Report (ICSR) processing, adhering to global pharmacovigilance guidelines and timelines.
Key Responsibilities:
- Perform ICSR case processing with a high degree of accuracy and compliance, ensuring data integrity and adherence to regulatory requirements.
- Conduct thorough case triaging to prioritize and manage incoming safety information effectively.
- Perform accurate and efficient data entry into the safety database, ensuring completeness and consistency of information.
- Compose clear, concise, and comprehensive narrative summaries of adverse events.
- Apply appropriate medical coding terminologies (e.g., MedDRA) to accurately classify adverse events.
- Adhere to global pharmacovigilance guidelines, Standard Operating Procedures (SOPs), and regulatory timelines.
- Collaborate effectively with cross-functional safety teams, including medical reviewers, data scientists, and regulatory affairs professionals.
- Maintain meticulous quality documentation, including case files, coding dictionaries, and training records.
- Contribute to audit readiness by ensuring compliance with internal and external quality standards.
- Stay up-to-date with evolving pharmacovigilance regulations and industry best practices.
- Participate in training programs to enhance your knowledge and skills in pharmacovigilance.
Required Qualifications & Skills:
- Bachelor’s degree in Pharmacy (B.Pharm), Nursing, Bachelor of Dental Surgery (BDS), Bachelor of Ayurvedic Medicine and Surgery (BAMS), Bachelor of Homeopathic Medicine and Surgery (BHMS), or a related Life Science discipline.
- Minimum of 1 to 5 years of experience in pharmacovigilance, specifically in ICSR processing.
- Strong understanding of ICSR concepts, safety reporting processes, and regulatory requirements (e.g., ICH guidelines, GVP).
- Proficiency in using safety databases and pharmacovigilance software applications.
- Excellent written and verbal English communication skills, with the ability to clearly and effectively convey complex information.
- Strong attention to detail, accuracy, and the ability to work independently and as part of a team.
- Willingness to work in rotational shifts, including evenings, weekends, and holidays as required.
- Must be willing and able to work from our office in Hinjewadi Phase 2, Pune, and relocate to Pune if necessary.
- Demonstrated ability to prioritize tasks, manage time effectively, and meet deadlines.
Benefits:
- Competitive salary commensurate with experience and qualifications.
- Opportunity to work within a leading pharmacovigilance team, gaining valuable experience and expanding your professional network.
- Structured training programs and opportunities for career growth and development.
- Exposure to global drug-safety standards and best practices.
- Comprehensive benefits package, including health insurance, paid time off, and retirement plan.
Walk-In Interview Details:
We are conducting a walk-in interview event for this position. Please bring the required documents and be prepared to spend the day with our team.
- Date: December 1st
- Time: 10:00 AM – 12:30 PM
- Location: Unit 2, Plot No 31, Hinjewadi Phase 2, Rajiv Gandhi Info Tech Park, Pune, Maharashtra, 411057
Contact Persons: Riya / Varsha
Documents to Bring:
- Updated Curriculum Vitae (CV)
- Original government-issued photo identification
Important Note:
The walk-in interview process will be a full-day program encompassing multiple rounds of interviews and assessments. Candidates are advised to come prepared and plan to stay for the entire duration of the event. We look forward to meeting you!