Pharmacovigilance Job at SUN Pharma
A rare chance has emerged at Sun Pharmaceutical Industries Ltd for the role of Manager-Medical Reviewer – ICSR in Gurgaon. This Pharmacovigilance Job is ideal for candidates with a background in pharmacovigilance and a commitment to ensuring drug safety. Interested applicants are encouraged to apply before the deadline.
Job Details:
- Job Title: Manager-Medical Reviewer – ICSR
- Location: Gurgaon – R&D
- Business Unit: Global Pharmacovigilance
- Job Grade: G11A
- Location: Gurugram
About Sun Pharmaceutical Industries:
Sun Pharmaceutical Industries Ltd is a leading global pharmaceutical company headquartered in India. It specialises in the development and manufacturing of a wide range of pharmaceutical formulations and active pharmaceutical ingredients. The company is dedicated to improving patient outcomes through innovative and high-quality medicines, operating in various therapeutic areas including cardiology, psychiatry, neurology, and more.
Responsibilities of the Pharmacovigilance Job:
- Perform medical review of ADR cases in Argus Safety
- Perform listedness assessment of ADR cases in Argus Safety
- Perform medical review of cases reported from the company sponsored clinical trials in Argus Safety
- Causality assessment note for BE CTs
- Perform activity of identification of clustering events in China monthly
- Perform sponsor reviews for the cases
- Ensure compliance to SOPs and regulatory guidelines and zero critical errors in medical review of cases as per quality metrics (QM)
- Attend and conduct assigned training sessions for the team
- Preparation of Risk Management Plans (RMPs)
- Draft/review Health Hazard Evaluation (HHE) reports
- Perform routine Targeted Follow up Activity
- Ensure compliance to applicable regulations and guidelines
- Receive applicable training for self-development
Job Requirements:
- Educational Qualification: MBBS / MD
- Experience: Tenure: 2+ Years
Competencies Required for the Pharmacovigilance Job:
Technical Competencies:
- Domain knowledge: Medical & therapeutic area knowledge; thorough knowledge of drug development process and pharmacology; Knowledge of Pharmacovigilance and Case processing
- Knowledge of regulatory and scientific guidelines
- Literature review & interpretation skills: Performing critical content reviews with clear objectives; logical and accurate research data interpretation
- Sound working knowledge and skills relating to Microsoft Office Applications and Argus safety database
- Keeping abreast of new relevant information in the pharmaceutical industry, and undergoing regular self-training to enhance skills
Behavioural Competencies / Soft Skills:
- Interpersonal skills and team spirit with willingness to help others in achieving targets
- Problem-solving skills & willingness to work in tight schedules if required by the organisation to support drug filings and approvals
- Communication skills
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