Precision Medicine Group
1001 - 5000 employees
Founded 2012
🧬 Biotechnology
⚕️ Healthcare Insurance
💊 Pharmaceuticals
💰 $35.2M Venture Round on 2021-03
Biotechnology • Healthcare Insurance • Pharmaceuticals
Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.
Safety Specialist II
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Precision Medicine Group
1001 - 5000 employees
Founded 2012
🧬 Biotechnology
⚕️ Healthcare Insurance
💊 Pharmaceuticals
💰 $35.2M Venture Round on 2021-03
Biotechnology • Healthcare Insurance • Pharmaceuticals
Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.
📋 Description
• Process ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans • Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory reportability • Enters data into Argus Safety Database • Code events, medical history, concomitant medications and tests • Draft case narratives • Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements • Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases • Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects • Participates in audits/inspections as required • Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process
🎯 Requirements
• Minimum 2 years of experience in clinical trial drug safety in the Pharma/CRO industry • Bachelor’s or first-level Degree in Pharmacy or Nursing preferred • Experience with Oracle Argus Safety Database • Working knowledge of MedDRA and WHODrug • Working knowledge of FDA safety regulations, EMA, MHRA and other ICH guidelines, and global safety regulations.
🏖️ Benefits
• Precision Medicine Group is an Equal Opportunity Employer. • Reasonable accommodation to complete application process. • Collaboration with global teams.
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