PHARMAFull-time
Associate Director, Triage and Medical Review
HYDERABAD (IN)HYBRIDPOSTED: 9/28/2026
PHARMAFull-time
HIRING ORGANIZATIONREGENERON PHARMACEUTICALS, INC.Pharmaceuticals
ROLE OVERVIEW
Associate Director leading end-to-end ICSR triage and medical review within Regeneron's Global Patient Safety POD in Hyderabad. The role combines clinical safety expertise, Argus-based case review, MedDRA coding, regulatory compliance and cross-functional leadership.
ROLE DEFINITION & RESPONSIBILITIES
- •Oversee Individual Case Safety Report medical review and accurate data capture in Argus
- •Lead triage harmonisation and end-to-end case quality across the India POD
- •Review narratives and author analyses, causality rationale and reporting decisions
- •Guide expectedness determinations against programmes, products and approved labelling
- •Oversee clinically appropriate MedDRA coding for adverse events and medical history
- •Partner with pharmacovigilance, risk management and clinical teams before regulatory submissions
- •Support compounds, case issue resolution, SOP development, process improvements and inspection readiness
- •Explore artificial intelligence technologies to strengthen pharmacovigilance activities
Reporting Hierarchy: Reports within Regeneron's Global Patient Safety organization and collaborates with the India Global Patient Safety POD, pharmacovigilance, 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 Indian registration or eligibility
- 10+ years of industry experience
- 7+ years of pharmacovigilance experience
- Hands-on ICSR review, narrative authoring, causality assessment, expectedness determination and MedDRA coding
- Expert knowledge of ICH E2A, E2B and E2D
- Knowledge of FDA and EMA pharmacovigilance regulations
- Proficiency with Argus Safety or equivalent safety databases
PREFERRED QUALIFICATIONS
- •Global development or marketed product experience
- •GPS POD experience
- •Insourced pharmacovigilance experience
- •Experience with AI technologies in pharmacovigilance
REQUIRED VERIFIED SKILLS
Individual Case Safety Reports
ICSR triage
medical review
Argus Safety
MedDRA
causality assessment
expectedness determination
narrative authoring
ICH E2A
ICH E2B
ICH E2D
FDA pharmacovigilance regulations
EMA pharmacovigilance regulations
case quality
pharmacovigilance
regulatory submissions
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Annual bonuses or other incentive plans, equity awards, pension or retirement benefits where applicable, health and wellness programs, insurance benefits, paid time off and family support benefits
The posting does not disclose a specific salary range or bonus percentage for the India role. It states that compensation is determined based on country, role level, skills and experience and may include incentive plans and equity awards.
ORGANIZATION CONTEXT & CULTURE
Regeneron is a science-driven biopharmaceutical company focused on discovering, developing and commercializing medicines for serious diseases through scientific innovation.
TEAM SIZE: 10,000+ employees
INDUSTRY: Pharmaceuticals
Culture: Regeneron emphasizes science, innovation, collaboration, patient impact and an inclusive workplace culture. The role supports global teams while operating in a hybrid Hyderabad environment.
EXPECTED CAREER ROADMAP
Potential progression includes broader global patient safety leadership, senior pharmacovigilance governance roles, safety strategy ownership and leadership of global safety programmes or teams.
APPLICATION ADVISORY
Emphasize MD/MBBS qualification and Indian registration eligibility; clearly demonstrate 10+ years of industry and 7+ years of pharmacovigilance experience; highlight ICSR medical review, causality, expectedness, MedDRA and Argus expertise; provide examples of case-quality leadership and regulatory inspection readiness; mention experience collaborating with global safety and clinical teams.
RECOMMENDED TRAINING
1/5
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