Safety & PV Specialist I
Location: Gurugram / Pune, India
Job ID: 25103034
Updated: November 11, 2025
Job Category: Pharmacovigilance / Drug Safety
Employment Type: Full-Time
About the Role
The Safety & PV Specialist I is responsible for the end-to-end processing of Individual Case Safety Reports (ICSRs) in compliance with global pharmacovigilance regulations. This role ensures timely and accurate safety reporting across clinical trial and post-marketing programs, supporting global drug safety operations for a leading biopharmaceutical solutions organization.
This position offers the opportunity to work within a collaborative, technology-driven environment committed to advancing patient safety and accelerating therapeutic innovations.
Key Responsibilities
ICSR Case Processing & Reporting
Perform data entry, booking, triage, and processing of ICSRs as per SOPs and safety management plans.
Evaluate ICSR accuracy, completeness, and regulatory reportability.
Enter case data in systems such as Argus or Aris-G.
Code events, medical history, concomitant medications, and laboratory tests using MedDRA.
Prepare complete narrative summaries for ICSRs.
Identify missing information, raise follow-up queries, and ensure resolution.
Support preparation and submission of expedited safety reports according to global regulations.
Conduct duplicate case identification and reconciliation.
Safety Data Quality & Compliance
Maintain safety tracking for project-related activities.
Perform literature review and safety-related screening.
Manage drug dictionary updates, maintenance, and MedDRA coding.
Validate and submit xEVMPD product records, ensuring accurate coding.
Participate in SPOR/IDMP activities as required.
Conduct quality review of ICSRs and ensure audit readiness.
File required safety documents in the Trial Master File (TMF) or Pharmacovigilance System Master File (PSMF).
Collaboration & Documentation
Foster effective communication with cross-functional teams and external stakeholders.
Participate in internal and external audits.
Ensure compliance with SOPs, Work Instructions, GCP, GVP, ICH guidelines, and global regulations.
Apply safety intelligence updates to daily operations.
Required Qualifications
Education (Mandatory)
B. Pharm / M. Pharm / BDS / BMS / MBBS
(No BSc / MSc profiles accepted)
Experience Required
2.5 to 4 years of proven experience in Pharmacovigilance and Safety Operations.
Hands-on experience in ICSR case processing is mandatory.
Working knowledge and experience with Argus or Aris-G safety databases.
Strong familiarity with medical and pharmacological terminology.
Experience in MedDRA coding, safety data review, and narrative writing.
Skills & Competencies
Strong analytical skills and attention to detail.
Ability to work with global teams under strict timelines.
Excellent written and verbal communication.
Understanding of global drug safety regulations and reporting requirements.
Ability to maintain accuracy and consistency across large data volumes.
Why Join This Organization
Opportunity to work with an organization that supported 94% of Novel FDA Approvals in the last five years.
Access to strong career development programs, technical training, and growth pathways.
Inclusive global culture that values diverse perspectives and professional excellence.
Exposure to advanced technologies and global clinical development processes.
Additional Information
This job description provides an overview of primary responsibilities and expectations. Additional tasks may be assigned based on project requirements. Equivalent education or experience may be considered. The organization adheres to global hiring regulations and provides reasonable accommodations as required.
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