Pharmaceutical Safety Specialist

4 weeks ago


Cambridge, Massachusetts, United States Proclinical Staffing Full time

Pharmaceutical Safety Specialist - Contract

Proclinical Staffing is seeking a dedicated Pharmaceutical Safety Specialist for a contract role.

Key Responsibilities:

The successful candidate will support the Case Management and Vendor Oversight team, manage documentation, assist with regulatory responses, and participate in quality control of documents.

Requirements:

  • Strong organizational and documentation management skills.
  • Ability to support regulatory responses and participate in quality control processes.
  • Experience with inspection readiness and maintaining archive sites.
  • Proficiency in collaborating with global teams and supporting system configurations.
  • Capability to collect and compile metrics and KPIs for safety case processing.

The Pharmaceutical Safety Specialist's responsibilities will be:

  • Support the CMVO team by managing documentation and assisting with regulatory responses.
  • Participate in quality control of documents and other assigned tasks.
  • Ensure inspection readiness by maintaining and archiving documentation in the eTMF.
  • Collaborate with the Global Safety Systems team to support configuration of requirements and reporting rules.
  • Collect and compile metrics and KPIs for clinical trial safety case processing activities.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.



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