Manager Medical Review

Biopharma Asia; Hyderabad; Presencial; INR 1.800.000 - 4.000.000; Jornada completa

Descripción de la vacante

Regeneron in Hyderabad seeks a Manager, Medical Review to lead end-to-end medical evaluation of Individual Case Safety Reports within defined timelines. You will refine case narratives and perform causality and expectedness determinations in collaboration with global partners.

The role requires an MD/MBBS with 7-9 years in pharmacovigilance, strong writing, and expertise in ICH guidelines and safety databases. On-site work is expected in Hyderabad, India.

Formación

• MD or MBBS with active registration or eligibility for registration with the relevant Indian regulatory body.
• 7-9 years of pharmacovigilance experience with hands-on medical review of Individual Case Safety Reports.
• Experience in narrative authoring, MedDRA coding, causality assessment, and expectedness determination.
• Strong knowledge of ICH E2A, E2B, E2D guidelines and FDA/EMA pharmacovigilance requirements.
• Proficiency with Oracle Argus Safety or equivalent safety database.

Responsabilidades

• Perform complete medical review of Individual Case Safety Reports within defined timelines.
• Review and strengthen case narratives, analyses of similar events, and reporting decisions.
• Determine expectedness using current reference safety information.
• Apply MedDRA coding to adverse events and medical histories.
• Collaborate with pharmacovigilance teams and clinical leads to produce submission-ready case documentation.
• Serve as a medical resource for Regeneron compounds and escalate complex issues.

Conocimientos

Narrative writing

MedDRA coding

Causality assessment

Expectedness determination

Clinical pharmacovigilance

Educación

MD or 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.

When & where

Location:Hyderabad

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 elevate complex issues when needed.

Contribute to standard operating procedures, process improvements, and inspection-readiness activities across Global Patient Safety.

Explore innovative ways to improve core activities through new technologies, including AI and generative AI.

This role requires

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.

Does this sound like you? 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. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and 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/. For other locations, additional information will be provided during the recruitment process.

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

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.

For jobs in Canada: this posting is for an existing position.