Position Summary:
The Safety Specialist II 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
- Other duties assigned by management
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 WHODrug
- Working knowledge of FDA safety regulations, EMA.MHRA and other ICH guidelines, and global safety regulations
#LI-Remote
#LI-TB1
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 [email protected].
Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at [email protected] so we can investigate and take appropriate action.
Skills 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 or other Life Science/health-related field or equivalent qualification
- Experience with Oracle Argus Safety Database
- Working knowledge of MedDRA
- Working knowledge of WHODrug
- Working knowledge of FDA safety regulations, EMA, MHRA, ICH guidelines, GVP and global safety regulations
- Immuno-oncology and Advanced Therapy Medicinal Products experience
Precision Medicine Group Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Precision Medicine Group and has not been reviewed or approved by Precision Medicine Group.
-
Healthcare Strength — Health coverage includes medical, dental, and vision with HSA/FSA options, plus disability and life insurance, forming a comprehensive core package. The lineup is presented as robust across wellbeing, time off, and financial security categories.
-
Leave & Time Off Breadth — Time off includes generous PTO and paid holidays, along with paid parental leave and adoption assistance. These offerings are positioned as part of a well-rounded benefits suite in the U.S. with similar cores noted in Canada.
-
Retirement Support — Retirement programs include a 401(k) with employer match in the U.S. and a group retirement plan in Canada. These elements help establish a competitive total rewards foundation.
Precision Medicine Group Insights
What We Do
We founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market. It involves utilizing technology, data, and human expertise. It is a big challenge that requires diverse talents. Our model involves both nurturing and investing organically and acquiring capabilities that we do not have but critically need. Our core executive team is anchored to this model, building life science services that address fundamental changes in healthcare that are necessary for health and outcomes improvement.
