Drug Safety Specialist Job at Proclinical Staffing, Cambridge, MA

aEVhWmxFUGd4L3IxWmtUa0I1bmwxWWtyNlE9PQ==
  • Proclinical Staffing
  • Cambridge, MA

Job Description

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 J anelle 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.

INDDS

Job Tags

Contract work,

Similar Jobs

PDS Tech, Inc.

Interior Craftsperson, Wood Finisher Job at PDS Tech, Inc.

 ...Be responsible for fabricating, installing, and refurbishing aircraft interiors with a focus on wood finishing. If you have a passion for high-quality craftsmanship and experience working on corporate aircraft, we want to hear from you! Job Title : I Finisher, Finishing... 

CHS Inc

Hazmat Truck Driver Job at CHS Inc

 ...employees in 19 countries. At CHS, we are creating connections to empower agriculture. Summary CHS Inc. is looking for a Hazmat Driver to join our team in Ortonville, MN or Wilmot, SD. This role will consist of completing local deliveries of propane to residential... 

UnitedHealthcare

Primary Care Physician - Greater New Orleans, LA Job at UnitedHealthcare

At UnitedHealthcare, were simplifying the health care experience, creating healthier communities and removing barriers to quality care. The work you do here impacts the lives of millions of people for the better. Come build the health care system of tomorrow, making it...

传神(中国)网络科技有限公司

Looking for English translators Job at 传神(中国)网络科技有限公司

:1. part-timeTranslate Chinese into English2.Position: free lance translator or Part-time translator

GRG USA LLC

GARAGE - Seasonal Sales Associate - Polaris Fashion Place Job at GRG USA LLC

Overview: We are a global fashion digital retailer with the Garage and Dynamite brands at the heart of our success. With over to 300 stores in Canada and the U.S., and more than 4,000 people, we have been making our mark on fashion retail since 1975. Our core strengths...