Safety Specialist

Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease. The Safety Specialist is an integral part of the safety team at Precision and performs all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR) for clinical trials and/or post-marketing safety programs.

Essential functions of the job include but are not limited to:

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 • Participate 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

Qualifications:

Minimum Required:

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 WHO Drug
• Working knowledge of FDA safety regulations, EMA.MHRA and other ICH guidelines, and global safety regulations

Preferred:

Early phase oncology clinical trial experience We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.