Job Title: Safety Specialist I
Location: Bangalore, Karnataka, India
Job Type: Regular Full-time
Division: Precision for Medicine
Business Unit: Clinical Solutions
Requisition Number: 6002
Position Summary
The Safety Specialist I is a vital member of the safety team at Precision. This role involves comprehensive management of individual case safety reports (ICSR) related to clinical trials and/or post-marketing safety programs.
Key Responsibilities
Process ICSRs in line with Standard Operating Procedures (SOPs) and project/program-specific safety plans.
Triage ICSRs; evaluate data for completeness, accuracy, and regulatory reportability.
Enter data into the Oracle Argus Safety Database.
Code events, medical history, concomitant medications, and tests.
Draft case narratives.
Assess and follow up on information queries until resolved satisfactorily.
Participate in timely, consistent, and accurate reporting of expedited reports per regulatory requirements.
Coordinate with data management for safety data reconciliation between clinical and safety databases.
Ensure distribution of individual expedited and periodic safety reports for clinical and post-marketing projects.
Support audits and inspections as needed.
Submit all relevant documents to the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF) per SOP and sponsor requirements.
Maintain compliance with SOPs, Work Instructions, global regulations (FDA, EMA, MHRA, ICH, GCP, GVP), and drug development processes.
Attend department meetings and participate in project-specific teleconferences/meetings.
Perform other duties assigned by management.
Qualifications
Minimum Required:
At least 2 years of experience in clinical trial drug safety within Pharma or CRO industry.
Bachelor’s or first-level Degree in Pharmacy or Nursing preferred; other Life Sciences or health-related qualifications acceptable.
Experience with Oracle Argus Safety Database.
Working knowledge of MedDRA and WHODrug coding dictionaries.
Familiarity with FDA safety regulations, EMA, MHRA, ICH guidelines, and global safety regulations.
Preferred:
Experience with early phase oncology clinical trials.
Knowledge of Immuno-oncology and Advanced Therapy Medicinal Products (ATMP).
Important Notices
Beware of fraudulent employment offers claiming association with our company. We do not extend job offers without formal communication from our recruiting team and a proper interview process.
All application data will be handled per our Privacy Policy.
Precision Medicine Group is an Equal Opportunity Employer, committed to non-discrimination based on race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other protected characteristics.
Reasonable accommodations are available for applicants with disabilities. Contact: QuestionForHR@precisionmedicinegrp.com
For suspected recruitment fraud, report to the FTC at https://www.ftc.gov.
About Precision Medicine Group
Precision Medicine Group is a team of experts specializing in advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. We assist pharmaceutical and life sciences clients in product development and commercialization in a dynamic environment.
Contact Email for Application Assistance: QuestionForHR@precisionmedicinegrp.com
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