Safety Specialist II

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $75M Private Equity Round on 2015-12

Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Perform all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR) for clinical trials and/or post-marketing safety programs. • Process ICSRs according to Standard Operating Procedures (SOPs) and project/program specific safety plans • Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability • Enters data into Argus Safety Database • Code events, medical history, concomitant medications and tests • Draft case narratives • Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved • 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 • Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate • 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 • Attends Department meetings • Participates in project specific teleconferences/meetings as required • Other duties assigned by management

🎯 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, but other Life Science, or other health-related field, or equivalent qualification. Immuno-oncology and Advanced Therapy Medicinal Products experience a plus. • 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

• Health insurance • Flexible work arrangements