Pharmacovigilance Drug Safety Physician – ProPharma | India
Job ID: JR 8555
Location: India
Position Type: Full Time
Experience Required: Relevant clinical and medical safety experience (Physician level)
Department: Pharmacovigilance / Drug Safety
ProPharma is hiring a Pharmacovigilance Drug Safety Physician to provide expert medical oversight across safety reporting, aggregate evaluations, and regulatory submissions for global pharmaceutical, biologic, and medical device programs. This role is ideal for licensed physicians seeking to advance their career in global drug safety and medical surveillance.
About ProPharma
For more than two decades, ProPharma has supported biotechnology, medical device, and pharmaceutical organizations in advancing scientific breakthroughs and launching innovative therapies. Through an advise-build-operate partnership model, the company delivers customized consulting solutions across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology.
Role Overview
The Pharmacovigilance Drug Safety Physician will provide medical review, safety signal assessment, and expert clinical insight for both individual case safety reports (ICSRs) and aggregate reports. The physician will support safety strategy throughout the product lifecycle, ensuring compliance with global regulatory standards and contributing to continuous safety surveillance.
Key Responsibilities
Provide expert medical review of safety events across pre-marketing, post-marketing, drug, and device programs.
Conduct medical assessment of ICSRs and document detailed pharmacovigilance comments.
Review and contribute to aggregate safety reports, including DSURs, PSURs/PBRERs, PADERs, ACOs, RMPs, and signal reports.
Perform clinical and diagnostic safety data review for case processing and aggregated submissions.
Evaluate literature search strategies and conduct literature-based medical assessments.
Serve as the primary safety physician contact for assigned projects throughout their lifecycle.
Participate as a member of the Signal Management Committee.
Support identification of out-of-scope project activities in coordination with the PV Project Lead.
Attend internal and client meetings, including investigator meetings and teleconferences.
Contribute clinical expertise to the development and maintenance of Company Core Data Sheets, Core Safety Information, and Product Information.
Provide guidance to pharmacovigilance teams on global adverse event reporting requirements.
Assist with development of project-specific procedures and medical review workflows.
Support QPPV and senior leadership in PV strategy and compliance initiatives.
Collaborate with internal and external medical reviewers to ensure consensus on safety evaluations.
Deliver training on clinical and medically relevant topics as required.
Provide overall PV and medical science oversight for assigned products.
Perform additional duties based on organizational needs.
Required Qualifications
MBBS (Bachelor of Medicine, Bachelor of Surgery) – Mandatory
Strong understanding of clinical practice and medical terminology
Experience in pharmacovigilance, drug safety, clinical research, or related medical review functions is preferred
Key Competencies
Expertise in medical and safety assessment
Strong analytical and interpretive skills
Ability to evaluate complex safety data
High-quality documentation and reporting abilities
Strong communication skills and stakeholder management capability
Commitment to regulatory compliance and high-quality standards
Why Join ProPharma
ProPharma is committed to building an inclusive work environment rooted in diversity, equity, and respect. Employees are encouraged to innovate, collaborate, and excel. Every application is personally reviewed by ProPharma’s recruitment team to ensure a transparent hiring process.
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