Medical Affairs Manager
Location: Sanathnagar, Hyderabad, Telangana, India (+1 additional location)
Employment Type: Permanent
Department: Medical Affairs
Experience Required: 6–9 Years
Educational Qualification: MBBS and/or MD (Pharmacology)
Job ID: HETERO6999
Updated Date: 30-12-2025
Job Overview
We are seeking a highly skilled Medical Affairs Manager to provide scientific and medical expertise across pharmacovigilance, clinical, and regulatory functions. The role involves medical review of safety data, aggregate reporting, signal management, regulatory compliance, and supporting benefit-risk assessments throughout the product lifecycle.
The ideal candidate will have strong clinical judgment, knowledge of ICSR processing, MedDRA coding, and global pharmacovigilance regulations, and experience contributing to regulatory submissions, clinical trials, and risk management activities.
Key Responsibilities
1. Medical Review & Case Management
Perform medical review and causality assessment of Individual Case Safety Reports (ICSRs).
Ensure accurate medical coding using MedDRA and WHO-DD.
Assess seriousness, expectedness, and relatedness of adverse events.
Provide medical judgment on special situations, including pregnancy, overdose, abuse, and medication errors.
2. Aggregate Safety & Signal Management
Contribute to signal detection, validation, and evaluation.
Review and author aggregate safety reports, including:
PSUR / PBRER
DSUR
Development Safety Update Reports
Support Risk Management Plans (RMPs) and safety specifications.
3. Regulatory & Compliance Activities
Ensure compliance with ICH-GCP, ICH-E2 guidelines, EU GVP, US FDA, and CDSCO regulations.
Support responses to regulatory authority queries.
Participate in inspections, audits, and CAPA implementation.
4. Safety Governance & Decision-Making
Participate in Safety Review Boards / DSMBs.
Support labeling updates and safety variations.
Contribute to benefit-risk assessments across the product lifecycle.
5. Secondary Responsibilities
Medical monitoring of in-house clinical trials and oversight of CRO medical monitoring for outsourced projects.
Develop and review clinical documents including protocols, investigator brochures, case record forms, prescribing information, and drug interaction documentation.
Organize Subject Expert Committee (SEC) meeting materials and attend SEC meetings for clinical trials and marketing approvals.
Evaluate new products for development opportunities.
Required Qualifications and Experience
Education: MBBS or MD (Pharmacology).
Experience:
MBBS: 9–10 years of relevant experience in medical affairs/pharmacovigilance.
MD (Pharmacology): 6–7 years of relevant experience.
Strong knowledge of medical review, pharmacovigilance, and clinical documentation.
Familiarity with regulatory submissions, safety governance, and clinical trial oversight.
Key Skills & Competencies
Medical Review & Case Assessment
Pharmacovigilance & Signal Management
MedDRA & WHO-DD Coding
Regulatory Compliance (US FDA, EU, CDSCO)
Clinical Trial Monitoring
Risk Management Plans & Safety Specifications
Benefit-Risk Assessment
Cross-Functional Collaboration & Communication
Why Join
Contribute to global pharmacovigilance and medical affairs operations.
Work with cross-functional teams in clinical, regulatory, and safety governance.
Drive scientific and medical strategy in a high-impact pharmaceutical environment.
Opportunity to develop as a key medical affairs professional with exposure to international regulations and clinical programs.
Explore more global Medical Affairs and pharmacovigilance roles at
thepharmadaily.com
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