Latest Pharmacy Jobs at Precision Medicine Group|Pharma Graduates Apply Now
The role of a Safety Specialist I at Precision is vital in ensuring patient safety across clinical trials and post-marketing programs. This job focuses on the collection, processing, and reporting of individual case safety reports (ICSRs) while adhering to global safety regulations and Good Clinical Practices (GCP). With responsibilities ranging from case triaging to regulatory submissions, this role offers an excellent opportunity to contribute to drug safety and compliance in a dynamic clinical research environment.
About Precision Medicine Group:
Precision Medicine Group is a leading healthcare company dedicated to providing innovative solutions in the field of precision medicine. We specialize in developing tailored medical treatments to meet the unique needs of patients, leveraging advanced technologies and data-driven insights.
Job Details:
- Role: Safety Specialist I
- Location: Bangalore, India
Position Summary:
The Safety Specialist I is an integral part of the safety team at Precision, performing all aspects of collecting, processing, and reporting individual case safety reports (ICSRs) for clinical trials and/or post-marketing safety programs.
Qualifications:
Minimum Required:
- Minimum 2 years of clinical trial drug safety experience
- Bachelor’s degree in Pharmacy, or related field
- Experience with Oracle Argus Safety Database
- Working knowledge of MedDRA, WHODrug, and safety regulations
Preferred:
- Early-phase oncology clinical trial experience
Essential Functions:
- Process ICSRs according to SOPs and project/program-specific safety plans
- Triages ICSRs and evaluates data for completeness and reportability
- Enter data into Argus Safety Database
- Code events, medical history, medications, and tests
- Draft case narratives and follow up on data queries
- Generate timely and accurate expedited reports in compliance with regulatory requirements
- Coordinate safety data reconciliation between databases
- Ensure timely distribution of required reports for projects
- Participate in audits and inspections
- Submit relevant documents to the TMF and Pharmacovigilance System Master File.
- Maintain compliance with SOPs, regulations, and guidelines
- Attend meetings and participate in project-specific activities
Keywords: Latest Pharmacy Jobs, Precision Medicine Group, Safety Specialist I, Clinical trial, Drug safety, Oracle Argus, Pharmacy, Healthcare, Precision medicine
