Lead medical review and case-quality activities for global pharmacovigilance programs in a hybrid Hyderabad role, ensuring safety cases are scientifically sound, compliant, and inspection-ready.

ROLE DEFINITION & RESPONSIBILITIES

•Lead end-to-end case quality from coding through causality assessment and final company comment
•perform and oversee medical review of ICSRs within defined time standards
•author and review case narratives and analyses of similar events
•assess causality and expectedness and document company rationale
•code adverse events and medical history using MedDRA
•collaborate with triage, PV, risk management, and clinical development teams
•drive SOP development, process improvement, and adoption of technologies including AI
•mentor Managers and junior reviewers on medical and regulatory standards.

Reporting Hierarchy: Reports within Regeneron's Global Patient Safety organization; leads and mentors Managers and junior medical reviewers while collaborating cross-functionally with triage, PV, risk management, and clinical development teams.

* Role responsibilities and qualifications synthesized based on industry benchmark standards.

QUALIFICATIONS & REQUIREMENTS

REQUIRED QUALIFICATIONS

MD or MBBS with active registration or eligibility for registration with the relevant Indian professional regulatory body
minimum 8-10 years of pharmacovigilance experience
hands-on ICSR medical review experience including narrative authoring, causality assessment, and expectedness determination
strong knowledge of ICH E2A, E2B, and E2D
knowledge of FDA and EMA pharmacovigilance regulations
proficiency with Argus Safety or equivalent safety database and MedDRA coding

PREFERRED QUALIFICATIONS

•Experience supporting global development programs or marketed products
•exposure to AI or generative AI tools in pharmacovigilance or clinical documentation
•experience leading or mentoring medical reviewers

REQUIRED VERIFIED SKILLS

Pharmacovigilance

ICSR medical review

Argus Safety

MedDRA

causality assessment

expectedness assessment

case narrative authoring

ICH E2A

ICH E2B

ICH E2D

FDA pharmacovigilance regulations

EMA pharmacovigilance regulations

safety case quality

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting

Bonus & Equity: Annual bonuses or other incentive plans; equity awards may apply depending on country and role

Benefits: Competitive and comprehensive total rewards package may include annual bonuses or incentive plans, equity awards, pension or retirement benefits, health and wellness programs, insurance benefits, paid time off, and family support benefits; benefits vary by country and role.

Salary range was not explicitly disclosed in the supplied India job description. Regeneron states that final offers are determined within the applicable country and role range based on skills and experience; bonuses, incentives, and equity may apply depending on country and role.

ORGANIZATION CONTEXT & CULTURE

Regeneron is a science- and innovation-driven biotechnology company focused on developing life-changing medicines for people with serious diseases, with global development and patient-safety operations.

TEAM SIZE: 10,000+ employees

INDUSTRY: Biopharmaceuticals

Culture: Science-driven, collaborative, inclusive, global, patient-focused culture with emphasis on scientific rigor, regulatory compliance, continuous improvement, and responsible technology adoption.

EXPECTED CAREER ROADMAP

Opportunity to lead global safety case-review activities, mentor medical reviewers, contribute to SOP and process improvements, support global development and marketed products, and participate in technology-enabled pharmacovigilance initiatives.

APPLICATION ADVISORY

Emphasize 8-10+ years of hands-on pharmacovigilance experience; highlight ICSR medical review, narrative writing, causality and expectedness assessment; demonstrate Argus and MedDRA proficiency; reference ICH E2A/E2B/E2D and FDA/EMA knowledge; showcase leadership, mentoring, and complex-case judgment; mention relevant AI or generative AI experience if applicable.

RECOMMENDED TRAINING

1/5

Industry Essentials of Pharmacovigilance

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