Jubilant Pharma Limited, a global leader in the pharmaceutical sector, is renowned for its diversified portfolio, which spans Specialty Pharmaceuticals and Generics & APIs. As a subsidiary, Jubilant Generics Limited (JGL) operates with excellence, housing state-of-the-art Research & Development units in Noida and Mysore, as well as world-class manufacturing facilities in Mysore, Karnataka, and Roorkee, Uttarakhand. The company’s stringent focus on quality and compliance has garnered approvals from top regulatory bodies, including the USFDA, Japan PMDA, UK MHRA, and WHO. The Mysore facility, covering 69 acres, is dedicated to API production, whereas the Roorkee facility specializes in dosage manufacturing, supporting a B2B model targeting EU, Canada, and emerging markets.
Key Responsibilities in the Role
As an Executive/Sr. Executive in Pharmacovigilance at Jubilant Generics, you will contribute to maintaining the highest standards in drug safety and compliance. Key responsibilities include:
- Literature Search and Analysis: Conducting thorough literature reviews to extract safety information pertinent to Jubilant’s products.
- Quality Check and Data Entry: Ensuring high-quality data entry and consistent processing of Individual Case Safety Reports (ICSRs) in the safety database as per company conventions.
- ICSR Allocation and Processing: Managing the timely distribution of ICSRs for various stages including data entry, quality review, and medical assessment.
- Aggregate Report Preparation: Compiling and drafting Periodic Adverse Drug Event Reports (PADERs) and other aggregate safety reports in alignment with company SOPs and regulatory mandates.
- Risk Management Plan (RMP) Compilation: Preparing and updating RMPs in adherence to company guidelines.
- Documentation and Compliance: Maintaining updated literature and QC checklists, ensuring the accurate archival of relevant documents, and tracking regulatory communications.
- Regulatory Compliance: Staying informed of current pharmacovigilance legislation to ensure the company meets global safety regulations.
- Training Completion: Successfully finishing assigned training modules as per company policy.
Qualifications and Experience
To qualify for the Executive/Sr. Executive – Pharmacovigilance role at Jubilant Generics Limited, candidates must meet the following criteria:
- Educational Background: A degree in Pharmacy, Life Sciences, or a related field.
- Experience: Prior experience in pharmacovigilance or related safety operations is essential.
- Regulatory Knowledge: Familiarity with global pharmacovigilance regulations, including those from the USFDA, EMA, and WHO, is highly preferred.
Essential Skills for Success
Candidates should demonstrate:
- Attention to Detail: High accuracy in data entry and quality review processes.
- Analytical Thinking: Strong capability to identify relevant safety information during literature reviews.
- Technical Proficiency: Knowledge of safety databases and regulatory submission processes.
- Documentation Skills: Ability to maintain accurate records and follow document archival protocols.
- Time Management: Efficient task handling to meet deadlines, ensuring all activities are completed in a timely manner.
- Communication Skills: Clear verbal and written communication, vital for collaborating with team members and reporting findings.
