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Drug Safety Specialist

1 month ago

cambridge, United States Proclinical Staffing Full time

Drug Safety Specialist - Contract - Cambridge, MA

Proclinical is seeking a dedicated Drug Safety Specialist for a role located in Cambridge, MA.

Primary Responsibilities:

The successful candidate will support the Case Management and Vendor Oversight (CMVO) team, manage documentation, assist with regulatory responses, and participate in quality control of documents. This position also involves ensuring inspection readiness by maintaining and archiving documentation, collaborating with the Global Safety Systems team, and compiling metrics and KPIs for clinical trial safety case processing activities.

Skills & 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 Drug 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.

If you are having difficulty in applying or if you have any questions, please contact Janelle Jones at J.Jones@proclinical.com.

Proclinical 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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