Safety submissions specialist

1 hour, 50 minutes ago
Full-time
Junior
Operations
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised

Description

  • Review and transmit individual case safety reports (ICSRs) for paper and electronic submission to regulatory agencies, business partners, affiliates, and other destinations.
  • Monitor the Drug Safety Inbox for incoming submission acknowledgements and confirmations of expedited reports.
  • Maintain submission-related trackers and spreadsheets, including distribution and submission logs.
  • Generate final clinical trial regulatory reports such as CIOMS I, MedWatch 3500A, and XML files from the global safety database.
  • Prepare and distribute final submission documents, including Investigator Safety Letters.
  • Perform case closure and electronically file SAE-related documentation.
  • Manage expedited report deviations, including initiation, investigation, extension requests, and CAPAs as needed.
  • Perform SAE reconciliation, send queries, and reconcile SUSAR Gap Packs.
  • Maintain and update expedited email distribution lists and compliance metrics.
  • Monitor regulatory intelligence sources for updates and provide country-specific reporting information to support Safety Reporting Plans.
  • Ensure documents are submitted to the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF) as required.
  • Maintain compliance with SOPs, Work Instructions, global drug/biologic/device regulations, GCP, ICH guidelines, GVP, and project/program plans.

Requirements

  • Minimum 2 years of experience in clinical trial drug safety in the Pharma/CRO industry.
  • Demonstrated knowledge and understanding of global safety reporting regulations and guidelines, including FDA, ICH, and EU pharmacovigilance requirements.
  • Knowledge of the ARGUS Safety Database.
  • Experience with EMA EudraVigilance, UK MHRA, and other recognized reporting portals.
  • BA/BS preferred.
  • Ability to maintain continuous knowledge of local and global safety reporting requirements.
  • Experience working under minimal supervision in a regulated safety or pharmacovigilance environment.
  • Familiarity with clinical trial and post-marketing documentation processes, including TMF and PSMF requirements.

Benefits

  • Precision Medicine Group offers an Equal Opportunity Employer workplace.
  • Reasonable accommodation is available for applicants with disabilities during the application process.
  • Privacy protections are provided through the company's Privacy Policy and CA Privacy Notice for California applicants.
  • The company maintains a formal interview process before any job offer is extended, helping protect applicants from fraudulent offers.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

Maintenance Technician II

Corvias 251-1K Construction & Engineering

Corvias is hiring a Maintenance Technician to perform community maintenance and repairs for residential properties while delivering timely, high-quality service and helping maintain safe, well-kept assets.

5 minutes ago

Data Entry Specialist, Remote

ABC Legal Services 251-1K Specialized Consumer Services

ABC Legal Services is hiring a remote e-File Specialist in Kentucky to review and file legal documents through internal online systems while supporting the e-Fulfillment and e-Filing team.

5 minutes ago

Safety Specialist

Olsson 1K-5K Construction & Engineering

Olsson is seeking an Environmental, Health, and Safety (EHS) Specialist to support engineering and construction project teams by strengthening safety culture, ensuring compliance, and developing firmwide EHS programs across the full project lifecycle.

5 minutes ago

OPERATIONS COORDINATOR

Inter 51-250 Banks

Inter is hiring for an Operations role focused on managing and improving operational processes to drive efficiency, quality, compliance, and stronger internal controls across the company.

5 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers