Manager Drug Safety Physician

Why This Role Matters

Drug Safety Physicians play a vital role in protecting patient health by ensuring the safety and proper monitoring of pharmaceutical products. They evaluate safety data, prepare regulatory safety reports, and work with global health authorities to maintain compliance with international pharmacovigilance standards.

Job Description

Cencora is hiring a Manager – Drug Safety Physician in Noida, India. This role involves leading pharmacovigilance activities, preparing regulatory safety reports such as PSUR and RMP, evaluating safety data, and ensuring regulatory compliance. The position also includes mentoring team members and coordinating with cross-functional teams to deliver high-quality drug safety documentation.

Key Features of the Role

• Position: Manager – Drug Safety Physician
• Company: Cencora (Affiliated Company: PharmaLex India Private Limited)
• Location: Noida, India
• Industry: Life Sciences / Pharmacovigilance / Consulting
• Employment Type: Full-Time
• Experience Required: 5–7 Years

Responsibilities

• Develop, author, and track safety reports including PSUR, RMP, DSUR, and ACO documents
• Ensure safety documentation is accurate, high-quality, and compliant with global regulatory requirements
• Conduct medical review and evaluation of safety data from databases, literature, and clinical trials
• Coordinate with internal teams to compile and review safety report content and annexes
• Monitor commitments related to safety documentation and ensure timely completion
• Manage logistical aspects of safety report preparation and regulatory submissions
• Track feedback from health authorities and implement required updates in safety reports
• Conduct peer review and quality control checks for safety documentation
• Prepare responses to regulatory authority queries related to drug safety
• Develop product-specific training materials for internal teams and external stakeholders
• Provide mentoring and guidance to pharmacovigilance team members
• Formulate safety strategies and perform integrated benefit-risk evaluations

Required Qualification

• MBBS or MD degree in Medicine

Important Requirements

• Minimum 5–7 years of experience in pharmacovigilance or drug safety
• Experience in medical review of aggregate safety reports and ICSRs
• Knowledge of regulatory guidelines and pharmacovigilance databases
• Experience with signal detection and safety surveillance
• Strong communication and organizational skills
• Ability to work in a fast-paced corporate life sciences environment

What We Offer

• Opportunity to work with a global healthcare and pharmaceutical services company
• Exposure to international pharmacovigilance and regulatory processes
• Collaborative work environment with global teams
• Professional development and leadership opportunities

Experience and Skills

• Pharmacovigilance and drug safety evaluation
• Medical review of aggregate safety reports
• Risk management and regulatory compliance
• Signal detection and safety data analysis
• Strong analytical and clinical judgement skills
• Leadership and mentoring capabilities

Company Overview

Cencora is a global healthcare company dedicated to improving health outcomes for people and animals worldwide. The organization supports pharmaceutical manufacturers, healthcare providers, and life sciences companies through innovative solutions, regulatory expertise, and healthcare services. With a strong global presence, Cencora focuses on advancing healthcare delivery and improving patient safety.

FAQs

1. What qualification is required for this role?
   Candidates must have an MBBS or MD degree in Medicine.

2. How much experience is required?
   A minimum of 5–7 years of experience in pharmacovigilance or drug safety is required.

3. Where is the job located?
   The position is based in Noida, India.

4. What safety reports will the candidate work on?
   The role involves working on PSUR, RMP, DSUR, ACO, and other pharmacovigilance safety reports.

Application Tips

• Highlight your pharmacovigilance and drug safety experience clearly
• Mention experience with aggregate safety reports such as PSUR and RMP
• Emphasize knowledge of regulatory guidelines and safety databases
• Include leadership or mentoring experience in pharmacovigilance teams