Manager Medical Review

Regeneron India Private Limited; Hyderabad; Presencial; INR 4.500.000 - 7.500.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centres

Insurance benefits

Paid time off

Family support benefits

Descripción de la vacante

Regeneron India Private Limited seeks an experienced Manager, Medical Review to lead end-to-end safety case reviews for global development programs and selected products from our India PV team. You will guide clinical judgement, causality, and expectedness while ensuring meticulous narratives and inspection-ready submissions.

You will collaborate with US- and EU-based partners, strengthen pharmacovigilance processes, and explore innovative technologies, including AI, to improve safety data

Formación

• MD/MBBS with active registration or eligibility in India.
• 7–9 years in pharmacovigilance including medical review of ICSRs.
• Experience in narrative writing, MedDRA coding, causality, and expectedness.
• Strong knowledge of ICH E2A/E2B/E2D and FDA/EMA reporting.
• Proficiency with Oracle Argus Safety.
• Ability to work independently with global cross-functional partners.
• Experience in global development programs or marketed products.
• Exposure to AI or generative AI tools in PV or clinical documentation.

Responsabilidades

• Perform complete medical review of ICSRs within defined timelines.
• Review and strengthen case narratives and causality justifications.
• Determine expectedness using reference safety information.
• Apply MedDRA coding to adverse events and histories.
• Collaborate with PV teams to produce submission-ready documentation.
• Serve as medical resource for Regeneron compounds; address questions.
• Contribute to SOPs, process improvements, and inspection readiness.
• Explore use of new technologies including AI.

Conocimientos

Pharmacovigilance

Medical review

Narrative writing

MedDRA coding

Causality assessment

Safety regulatory knowledge

Independence with global teams

AI exposure in PV

Educación

MD/MBBS

Herramientas

Oracle Argus Safety

Descripción del empleo

Build our future together At Regeneron, Global Patient Safety helps protect patients by ensuring safety information is evaluated with scientific rigor and documented to the highest quality standards.

As Manager, Medical Review, you will join our India-based Global Patient Safety POD and lead the end-to-end medical review of Individual Case Safety Reports from global development programs and selected marketed products. Your clinical judgement will shape accurate coding, expectedness and causality decisions, clear case narratives, and inspection‑ready submissions. Working closely with triage colleagues and US- and EU-based safety partners, you will help create cohesive case documentation, strengthen pharmacovigilance processes, and explore responsible uses of new technologies, including AI.

Discover your role

• Perform complete medical review of Individual Case Safety Reports within defined timelines, ensuring clinically important information is accurately captured.
• Review and strengthen case narratives, analyses of similar events, company causality rationales, and reporting decisions.
• Determine expectedness using current reference safety information, including investigator brochures, US prescribing information, and summaries of product characteristics.
• Apply clinically appropriate MedDRA coding to adverse events and medical histories in line with Global Patient Safety standards.
• Partner with pharmacovigilance teams, risk management leads, and clinical development leads to produce cohesive, submission‑ready case documentation.
• Serve as a medical resource for assigned Regeneron compounds, resolve case-level questions, and escalation complex issues when needed.
• Contribute to standard operating procedures, process improvements, and inspection-ready activities across Global Patient Safety.
• Explore innovative ways to improve core activities through new technologies, including AI and generative AI.

Job Qualifications

• An MD or MBBS, with active registration or eligibility for registration with the relevant Indian professional regulatory body.
• 7-9 years of pharmacovigilance experience, including hands‑on medical review of Individual Case Safety Reports.
• Demonstrated experience in narrative authoring, MedDRA coding, causality assessment, and expectedness determination.
• Strong knowledge of ICH E2A, E2B, and E2D guidelines, along with FDA and EMA pharmacovigilance requirements for case processing and expedited reporting.
• Proficiency with Oracle Argus Safety or an equivalent safety database, supported by sound clinical judgement and clear written reasoning.
• The ability to work independently while collaborating effectively with global, cross‑functional partners.
• Experience supporting global development programs or marketed products.
• Experience in a Global Patient Safety POD, insourced pharmacovigilance model, or similar integrated operating structure.
• Exposure to AI or generative AI tools in pharmacovigilance, safety review, or clinical documentation.

Benefits

• Annual bonuses or other incentive plans.
• Equity awards.
• Pension or retirement benefits.
• 401(k) company match.
• Health and wellness programs.
• Fitness centres.
• Insurance benefits (e.g., medical, dental, vision, life and disability).
• Paid time off.
• Family support benefits.

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

Equal Opportunity & Diversity

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

Background Checks

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

Location

Hyderabad

Job Nature

Many roles are required to be performed on‑site. Please be advised that at Regeneron, we believe we do our best work when we are together.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award-winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.