Senior Drug Safety Manager Jobs at Sun Pharmaceutical Industries

Sun Pharmaceutical Industries Ltd; Gurugram District; Hybrid; INR 2,800,000 - 4,200,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd in Gurugram is seeking a seasoned Pharmacovigilance Manager to lead end-to-end drug safety activities for NCE programs across development, registration, and post-approval stages. This senior role requires strong regulatory expertise and cross-functional collaboration with global teams.

The ideal candidate has MD/MBBS or doctoral qualifications, 7–8 years in pharmacovigilance, and proven experience in aggregate reporting, signal management, and regulatory

Qualifications

• MD, MBBS, or Doctorate in Life Sciences, Pharmacy, or Medicine.
• 7 to 8 years of hands-on experience in Pharmacovigilance or Drug Safety.
• Experience with aggregate reporting, signal management, and regulatory interactions.

Responsibilities

• Lead end-to-end drug safety activities for assigned NCE programs.
• Define safety data acquisition strategies and analytical approaches.
• Review protocols, safety management plans, and reporting requirements.
• Oversee signal detection, documentation, and evaluation.
• Prepare DSURs, PSURs, and PBRERs.
• Collaborate with global teams and CROs.

Skills

Pharmacovigilance

Regulatory interactions

Safety data analysis

Cross-functional collaboration

Education

MD/MBBS or Doctorate in Life Sciences

Tools

PV databases

Job description

Sun Pharma hiring Pharmacovigilance Manager in Gurugram. MD/MBBS candidates with 7–8 years experience. Senior PV vacancy.

Sun Pharmaceutical Industries Ltd is inviting applications from experienced pharmacovigilance professionals for the role of Pharmacovigilance Manager at its Gurugram facility. This is a senior-level opportunity for candidates who have worked across clinical development and post-marking drug safety functions and are comfortable handling global regulatory requirements. The role offers direct involvement with New Chemical Entities, global safety governance, and regulatory interactions, making it a strong career move for professionals aiming for leadership positions in pharmacovigilance and drug safety.

Company Overview

Sun Pharmaceutical Industries Ltd is India’s largest pharmaceutical company and a globally respected name in specialty generics and innovative medicines. With a presence in more than 100 countries, the company supports complex drug development programs across multiple therapeutic areas.

Sun Pharma’s strong focus on research and development enables the advancement of New Chemical Entities, specialty formulations, and differentiated therapies. The organization follows stringent compliance standards aligned with global regulatory authorities such as USFDA, EMA, and Health Canada. Its pharmacovigilance systems are designed to ensure patient safety, regulatory compliance, and continuous benefit–risk evaluation throughout the product lifecycle.

A career at Sun Pharma offers stability, global exposure, and the opportunity to work on high-impact healthcare programs that directly influence patient outcomes worldwide.

Job Role & Responsibilities

The Pharmacovigilance Manager will be responsible for leading end-to-end drug safety activities for assigned New Chemical Entities across development, registration, and post-approval phases. This role requires strong scientific judgment, regulatory expertise, and cross-functional coordination.

Key Responsibilities

• Lead pharmacovigilance safety activities for assigned NCE programs
• Ensure timely completion of safety deliverables in line with global PV regulations and internal SOPs
• Define safety data acquisition strategies, methodologies, and analytical approaches
• Review clinical study protocols, safety management plans, and safety reporting requirements
• Review and assess adverse events and serious adverse events from clinical trials
• Evaluate safety outputs including tables, figures, listings, Clinical Study Reports, and Investigator Brochures
• Support the development of safety-related data collection tools and case report forms

Signal Management and Aggregate Reporting

• Oversee signal detection, documentation, tracking, and evaluation activities
• Conduct and monitor literature surveillance for safety signals
• Plan, prepare, and review aggregate safety reports, including:
  • Development Safety Update Reports (DSURs)
  • Periodic Safety Update Reports (PSURs)
  • Periodic Benefit Risk Evaluation Reports (PBRERs)
  • Addendum Clinical Overviews (ADCOs)
  • Line listings and cumulative safety summaries

Regulatory and Compliance Activities

• Manage responses to regulatory authority queries and RFIs from USFDA, EMA, Health Canada, and PRAC
• Support new drug applications and global regulatory submissions from a pharmacovigilance perspective
• Review product labelling and provide safety justification documents
• Contribute to benefit–risk evaluations and Risk Management Plan development
• Participate in safety governance forums, internal audits, and regulatory inspections

Cross-Functional Collaboration

• Collaborate with Clinical Development, Regulatory Affairs, Medical Writing, Labelling, QPPV teams, and CRO partners
• Act as an interface between global project leaders, CROs, and internal stakeholders
• Support aligned decision-making across global safety programs

Educational Qualification

Candidates must hold one of the following qualifications:

• MD, MBBS, or Doctorate in Life Sciences, Pharmacy, or Medicine

Relevant courses include: MD Pharmacology, MD Clinical Pharmacology, MBBS, PharmD, MPharm Pharmacology, MPharm Pharmaceutics, PhD Life Sciences, PhD Pharmacy, PhD Clinical Research, MSc Pharmacology, MSc Clinical Research

Experience Requirements

• 7 to 8 years of hands‑on experience in Pharmacovigilance or Drug Safety
• Strong exposure to clinical trial safety and post-marketing pharmacovigilance
• Proven experience in aggregate reporting, signal management, and regulatory interactions
• Experience working with global teams and CROs

Key Skills

• Strong understanding of ICH, EMA, and USFDA pharmacovigilance regulations
• Expertise in benefit–risk assessment and safety documentation
• Excellent communication and stakeholder management skills
• Ability to manage multiple global safety deliverables simultaneously

Location & Salary

• Job Location: Gurugram, Haryana
• Work Model: Hybrid
• Employment Type: Full-time
• Salary: Competitive and aligned with senior pharmacovigilance industry standards

This role offers long-term growth, leadership exposure, and involvement in global drug development programs.

Who is eligible to apply for this role?

Candidates with MD, MBBS, PharmD, MPharm, PhD, or MSc qualifications and 7–8 years of pharmacovigilance experience are eligible.

Is this job suitable for freshers?

No. This is a senior-level pharmacovigilance position requiring significant industry experience.

Does this role involve regulatory authority interaction?

Yes. The role includes direct communication with global regulators such as USFDA, EMA, and Health Canada.

What type of pharmacovigilance work is involved?

The role covers clinical trial safety, post-marketing surveillance, signal management, aggregate reporting, and risk management.

Is the position remote?

No. This is a hybrid role based in Gurugram, Haryana.