Associate Director – Triage and Medical Review
Company: Regeneron
Location: Hyderabad, Telangana, India
Work Arrangement: Hybrid – 3 days per week on-site
Function: Global Patient Safety
Job ID: R47768
Level: Associate Director
Position Overview
Regeneron is seeking an experienced Associate Director to join its Global Patient Safety team and support global development programs.
The role is responsible for leading end-to-end Individual Case Safety Report (ICSR) triage and medical review activities while ensuring high standards of data quality, medical assessment, regulatory compliance, and case processing.
The Associate Director will collaborate closely with global pharmacovigilance, clinical development, risk management, and other cross-functional teams. The position also provides an opportunity to contribute to process improvement, inspection readiness, and the application of emerging technologies such as artificial intelligence within pharmacovigilance.
Key Responsibilities
ICSR Triage and Medical Review
Oversee medical review of Individual Case Safety Reports (ICSRs).
Ensure accurate and complete safety data capture within Argus or applicable safety databases.
Lead end-to-end case triage and medical review activities.
Drive harmonization of triage processes across the India Global Patient Safety POD.
Ensure consistent case quality throughout the ICSR lifecycle.
Review and assess case narratives for medical accuracy and completeness.
Author or review medical analyses and clinical rationales.
Perform and oversee causality assessments.
Review and support appropriate regulatory reporting decisions.
Expectedness and Labeling Assessment
Evaluate the expectedness of adverse events against applicable products, programs, and approved labeling.
Apply clinical judgment when determining whether events meet expectedness criteria.
Ensure assessments are supported by clear and scientifically sound rationale.
Maintain consistency between medical assessments and applicable product labeling.
MedDRA Coding and Medical Data Review
Oversee clinically appropriate MedDRA coding of adverse events.
Review medical history coding for accuracy, consistency, and clinical relevance.
Ensure coding decisions are medically appropriate and aligned with pharmacovigilance requirements.
Provide guidance on complex coding issues and medical terminology.
Regulatory and Pharmacovigilance Compliance
Maintain expert knowledge of global pharmacovigilance regulations and safety reporting requirements.
Apply relevant ICH and Health Authority requirements to case review activities.
Ensure compliance with:
ICH E2A
ICH E2B
ICH E2D
FDA pharmacovigilance requirements
EMA pharmacovigilance requirements
Support regulatory submission readiness and ensure appropriate case decisions are made before submission.
Contribute to inspection readiness activities.
Support the development and maintenance of SOPs and pharmacovigilance procedures.
Cross-Functional Collaboration
Partner with Pharmacovigilance, Risk Management, Clinical Development, and other relevant teams.
Collaborate with global safety and clinical development stakeholders before regulatory submissions.
Support resolution of complex case-related issues.
Provide medical and pharmacovigilance expertise to cross-functional teams.
Ensure effective communication and alignment across global programs and teams.
Process Improvement and Innovation
Identify opportunities to improve ICSR triage, medical review, and case quality processes.
Support the development and implementation of process improvements.
Contribute to standardization and harmonization of pharmacovigilance activities.
Explore and evaluate artificial intelligence technologies that may strengthen pharmacovigilance processes.
Promote efficient, consistent, and high-quality safety operations.
Leadership Responsibilities
Lead triage and medical review activities within the India Global Patient Safety POD.
Provide technical and medical guidance to team members.
Promote consistent application of pharmacovigilance standards and processes.
Support case issue resolution and escalation of complex safety matters.
Contribute to the development of team capabilities and best practices.
Maintain high standards of quality, compliance, and scientific rigor.
Required Qualifications
MD or MBBS degree.
Active Indian medical registration or eligibility for registration.
10+ years of relevant industry experience.
At least 7 years of experience in pharmacovigilance.
Extensive hands-on experience with ICSR medical review.
Experience in narrative authoring.
Strong experience with causality assessment.
Experience performing expectedness determinations.
Strong knowledge and practical experience with MedDRA coding.
Proficiency with Argus Safety or an equivalent pharmacovigilance safety database.
Regulatory Knowledge
Strong knowledge of international pharmacovigilance regulations and guidelines, particularly:
ICH E2A – Definitions and Standards for Expedited Reporting.
ICH E2B – Electronic Transmission of Individual Case Safety Reports.
ICH E2D – Post-Approval Safety Data Management.
FDA pharmacovigilance and safety reporting requirements.
EMA pharmacovigilance requirements and guidelines.
Key Competencies
Strong clinical judgment.
Excellent medical reasoning and analytical skills.
Ability to develop clear and defensible medical rationales.
Strong understanding of the complete ICSR lifecycle.
Excellent written and verbal communication skills.
Strong attention to detail.
Ability to manage complex safety cases and make appropriate decisions.
Strong leadership and stakeholder management skills.
Ability to work effectively with global, cross-functional teams.
Strong understanding of regulatory compliance and patient safety.
Ability to identify opportunities for process improvement and innovation.
Preferred Experience
Experience supporting global drug development programs.
Experience with marketed pharmaceutical products.
Previous experience within a Global Patient Safety POD.
Experience working in an insourced pharmacovigilance model.
Experience supporting complex global safety operations.
Exposure to artificial intelligence or technology-enabled pharmacovigilance solutions.
About Regeneron
Regeneron is a science-driven biotechnology company focused on developing life-changing medicines for people living with serious diseases.
Its teams work across research, clinical development, regulatory, and patient safety functions to advance innovative therapies and improve patient outcomes globally.
Work Environment
This position is based in Hyderabad and follows a hybrid working model, with an expectation of working on-site three days per week.
Regeneron emphasizes collaboration, accountability, scientific excellence, and an inclusive workplace culture.
Compensation and Benefits
Regeneron provides a competitive total rewards package, which may vary by country and role. Depending on location and eligibility, benefits may include:
Annual bonuses or other incentive programs.
Equity awards.
Pension or retirement benefits.
Health and wellness programs.
Medical, dental, and vision insurance.
Life and disability insurance.
Paid time off.
Family support benefits.
Other country-specific employee benefits.
Equal Employment Opportunity
Regeneron is an equal opportunity employer committed to building an inclusive workplace. Qualified applicants are considered without discrimination based on legally protected characteristics under applicable laws.
Reasonable accommodations may be provided to applicants with disabilities or chronic illnesses during the recruitment process, where required by applicable law.
Employment and Background Checks
Employment is subject to the candidate having the legal right to work in the country where the position is based.
Depending on applicable local laws, Regeneron may conduct background checks as part of the recruitment process to verify information such as identity, work authorization, and educational qualifications.
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