Skip to main content

This job has expired

Medical Reviewer/Safety Reviewer II

Employer
Proclinical Staffing
Location
USA, Chicago, Illinois
Salary
Highly Competitive Salary
Start date
16 Mar 2023
Closing date
30 Mar 2023

View more

Job Details

Proclinical is seeking a Medical Reviewer/Safety Reviewer for a top pharmaceutical company located in Illinois.

Must be eligible to work or be a citizen in the US.

Job Responsibility:

  • Reviews and analyzes safety-related data from clinical trials including adverse events.
  • Timely assessment of adverse event coding for consistency and accuracy of coding.
  • Timely, accurate and effective medical review of safety-related eCRFs including labs, vital signs, cardiac, medications, medical history, and communicates with Study Lead any findings.
  • May participate in safety surveillance activities for assigned studies, including assisting with regulatory responses and ad hoc data analysis.
  • Adheres to regulatory guidance, Protocols, departmental processes and policies under minimum supervision.
  • Medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings.
  • May manage the activities of regional contract CRAs, and organizes the files and budgets associated with several clinical studies.
  • Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database.
  • Off-label information would be disseminated at this level.
  • May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification.

Skills and Requirements:

  • 3-5 year's experience level.

If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at (+1) 617-830-1769 or b.forsen@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.

#LI-BF1

Company

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Company info
Website
Telephone
0800 988 4437
Location
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert