PHARMAFull-time
Senior Manager Medical Review
HYDERABAD (India)HYBRIDPOSTED: 9/25/2026
PHARMAFull-time
HIRING ORGANIZATIONREGENERONBiopharmaceuticals
ROLE OVERVIEW
Senior Pharmacovigilance Medical Review role leading end-to-end ICSR medical review, case quality, causality assessment, safety narratives, regulatory compliance and team mentoring within Regeneron's Global Patient Safety organization.
ROLE DEFINITION & RESPONSIBILITIES
- •Lead end-to-end ICSR case quality from coding through causality and final company comment
- •perform and oversee medical review of ICSRs within defined timelines
- •author and review case narratives and similar-event analyses
- •assess company causality rationale and expectedness
- •code adverse events and medical history using MedDRA
- •collaborate with triage, PV, risk management and clinical development teams
- •act as medical resource for assigned compounds and resolve complex cases
- •drive SOP development, process improvement and AI-enabled technology integration
- •mentor managers and junior reviewers
Reporting Hierarchy: Team lead within Global Patient Safety; collaborates with triage, pharmacovigilance, risk management and clinical development teams across India, US and EU; specific direct reporting manager not stated
* 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
- 8-10 years of pharmacovigilance experience
- hands-on ICSR medical review experience
- narrative authoring, causality assessment and expectedness determination
- knowledge of ICH E2A, E2B and E2D
- knowledge of FDA and EMA pharmacovigilance regulations
- proficiency with Argus Safety or equivalent safety database
- MedDRA coding
- strong clinical judgment and written communication
PREFERRED QUALIFICATIONS
- •Experience supporting global development programs or marketed products
- •exposure to AI or generative AI tools in pharmacovigilance or clinical documentation
REQUIRED VERIFIED SKILLS
Pharmacovigilance
ICSR medical review
case narratives
causality assessment
expectedness assessment
MedDRA
Argus Safety
ICH E2A
ICH E2B
ICH E2D
FDA pharmacovigilance
EMA pharmacovigilance
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Competitive total rewards package; annual bonus or incentive plans may apply; health and wellness programs; insurance benefits; retirement benefits; paid time off; family support benefits
The posting states that salary ranges may be disclosed by country, but no India-specific salary range was provided; INR used as the location-based currency.
ORGANIZATION CONTEXT & CULTURE
Regeneron is a science-driven biopharmaceutical company focused on developing medicines for serious diseases through research and innovation.
TEAM SIZE: 10,000+ employees globally (inferred from company scale)
INDUSTRY: Biopharmaceuticals
Culture: Science-driven and inclusive culture emphasizing collaboration, innovation, patient impact and professional development.
EXPECTED CAREER ROADMAP
Potential progression into Associate Director or broader Global Patient Safety and Pharmacovigilance leadership roles based on experience and performance.
APPLICATION ADVISORY
Emphasize 8-10+ years of pharmacovigilance experience, hands-on ICSR medical review, narrative writing, causality and expectedness assessment, Argus Safety, MedDRA and ICH/FDA/EMA regulatory knowledge.
RECOMMENDED TRAINING
1/5
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