At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
Job Profile
- Preparation and review of Risk Management Plans (RMPs) and Direct Healthcare Professional Communication (DHPC) letters in alignment with global regulatory requirements
- Preparation and maintenance of the Pharmacovigilance System Master File (PSMF)
- Development of Health Hazard Analysis (HHA) documents, including comprehensive risk evaluation
- Expertise in risk characterization, including identification, evaluation, and documentation of the risks
- Analysis of Individual Case Safety Reports (ICSRs) within aggregate contexts, assessing seriousness, expectedness, and causality, and integrating findings into cumulative safety profiles for molecules
- Systematic review of published scientific literature to support safety evaluation in RMPs
- Active participation in pharmacovigilance projects, including collation and preparation of responses to regulatory authority assessment reports
Competencies Required:
- Proficiency in causality assessment, MedDRA coding, and technical scientific writing, with hands-on experience in preparing Safety sections (Part II, part III & Part V) of Risk Management Plans (RMPs)
- Analysis of Individual Case Safety Reports (ICSRs) within aggregate contexts to perform benefit risk evaluation
Knowledge on preparation of Health Hazard Analysis (HHA) documents
