423491 Principal Scientist, ICSR management, PV Ops (Open)

Job Summary

The Principal Scientist in ICSR management and Pharmacovigilance Operations is responsible for the day-to-day management of Adverse Event (AE), incident, and pregnancy reports across all countries within the Hub. This role is crucial for ensuring compliance with local regulations and maintaining the integrity of safety data exchange with licensing partners.

Responsibilities

• Manage daily operations related to Adverse Event (AE), incident, and pregnancy reports.
• Ensure compliance with local regulations for reporting to regulatory authorities within mandated timeframes for expedited reports.
• Provide training to authorized external third parties and internal stakeholders on literature review, adverse event reporting, and medical information queries.
• Monitor and document local medical and scientific literature to identify unindexed reports and conduct monthly literature reviews.
• Liaise with relevant departments regarding product complaints and medical inquiries, ensuring proper notification to the Named Safety Contact (NSC).
• Oversee the governance of Pharmacovigilance/Medical Information operations within designated clusters and coordinate central requests.

Qualifications

• Advanced degree in Life Sciences, Pharmacy, or a related field (e.g., PhD, MSc).
• Strong knowledge of pharmacovigilance regulations and practices.
• Excellent communication and interpersonal skills.
• Proficiency in data management and reporting tools.
• Ability to work collaboratively in a cross-functional team environment.
• Strong analytical and problem-solving skills.
• Experience in training and mentoring staff.
• Familiarity with local and international regulatory requirements.

Preferred Skills

• Experience in clinical studies and safety data management.
• Knowledge of medical information processes and product complaint handling.
• Familiarity with electronic reporting systems and databases.

Experience

• Minimum of 5-7 years of relevant experience in pharmacovigilance or related fields, with a focus on adverse event management.

Environment

• Work setting is hybrid, combining both in-office and remote work. The position is based in Bengaluru Luxor North Tower.

Salary

• Estimated salary range: ₹6,500,000 per annum.