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Precision For Medicine, a global leader in clinical research and precision medicine, is hiring a Safety Specialist I in Bengaluru, Karnataka, India. This is a full-time, on-site role for professionals passionate about drug safety, pharmacovigilance, and clinical trials. If you have experience with ICSR processing, Oracle Argus, and MedDRA/WHODrug coding, this role offers a dynamic career opportunity in the fast-growing life sciences sector.
Key Responsibilities
As a Safety Specialist I, you will:
- Process and manage Individual Case Safety Reports (ICSRs) as per SOPs and project-specific safety plans.
- Triages and evaluate ICSR data for completeness, accuracy, and regulatory reportability.
- Enter data into the Oracle Argus Safety Database.
- Perform medical coding of events, history, medications, and tests.
- Draft and finalize case narratives.
- Query missing safety information and ensure timely resolution.
- Generate and submit expedited reports in compliance with global regulatory requirements.
- Collaborate with data management teams for safety database reconciliation.
- Ensure submission of safety documents to TMF and pharmacovigilance systems.
- Participate in audits, inspections, and project meetings.
- Maintain strong compliance with ICH-GCP, GVP, FDA, EMA, and global PV regulations.
Qualifications
Minimum Requirements:
- Bachelorโs degree in Pharmacy, Nursing, Life Sciences, or related field.
- 2+ yearsโ experience in clinical trial drug safety within Pharma or CRO.
- Hands-on experience with Oracle Argus Safety Database.
- Knowledge of MedDRA, WHODrug, and global pharmacovigilance regulations.
Preferred:
- Early-phase oncology clinical trial experience.
- Exposure to immuno-oncology and advanced therapy medicinal products (ATMPs).
Why Join Precision For Medicine?
- Work with a global leader in precision medicine and clinical research.
- Gain exposure to innovative oncology and immunotherapy studies.
- Be part of a diverse, collaborative, and mission-driven safety team.
- Competitive salary and benefits package.
- Opportunities for career growth in pharmacovigilance and drug safety.
How to Apply
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