Job Description – Safety Specialist I
Company: Precision for Medicine
Location: Bangalore, Karnataka, India
Job Type: Regular, Full-time
Division: Precision for Medicine – Clinical Solutions
Requisition Number: 6002
Position Summary
The Safety Specialist I plays a key role in the Safety Team at Precision for Medicine, handling all aspects of Individual Case Safety Reports (ICSRs) processing, collection, and reporting for clinical trials and/or post-marketing safety programs.
Key Responsibilities
Process ICSRs according to SOPs and project/program-specific safety plans.
Triage and evaluate ICSR data for completeness, accuracy, and regulatory reportability.
Enter data into Argus Safety Database.
Code events, medical history, concomitant medications, and tests.
Draft case narratives with accuracy and clarity.
Assess missing information, generate queries, and ensure resolution.
Generate expedited safety reports in compliance with global regulatory requirements.
Coordinate with Data Management staff for safety data reconciliation between clinical and safety databases.
Ensure distribution of all required expedited and periodic reports for clinical and post-marketing projects.
Submit relevant documents to:
Trial Master File (TMF) for clinical trials.
Pharmacovigilance System Master File (PSMF) for post-marketing programs.
Support audits/inspections as required.
Maintain compliance with: SOPs, WIs, GCP, ICH guidelines, GVP, global safety regulations, and project-specific plans.
Participate in department meetings, project-specific teleconferences, and cross-functional discussions.
Perform other duties assigned by management.
Qualifications
Minimum Required
Education:
Bachelor’s or first-level degree in Pharmacy or Nursing preferred.
Other Life Sciences or Health-related fields considered.
Experience:
Minimum 2 years of experience in clinical trial drug safety within Pharma/CRO industry.
Hands-on experience with Oracle Argus Safety Database.
Strong working knowledge of MedDRA and WHODrug coding dictionaries.
Familiarity with FDA, EMA, MHRA, and ICH global safety regulations.
Preferred
Experience in early-phase oncology clinical trials.
Exposure to Immuno-oncology and Advanced Therapy Medicinal Products (ATMPs).
Work Environment & Compliance
Office-based role in Bangalore, Karnataka.
Must comply with company SOPs, Work Instructions, and regulatory requirements.
Participation in audits/inspections as required.
Important Notice
Precision for Medicine has been made aware of fraudulent job offers being circulated by individuals/organizations impersonating the company. Please note:
Genuine job offers are only made following direct communication with our recruiting team, hiring managers, and a formal interview process.
If contacted with an unsolicited offer, please verify its authenticity with Precision for Medicine before proceeding.
✨ This structured role is ideal for professionals with drug safety/pharmacovigilance experience looking to contribute to global clinical research and post-marketing safety programs.
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