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Job Details

Safety Physician

Company: United BioSource Corporation.
Location: Philadelphia, PA
Reference: REQ20012106
Closing Date: 23 May 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Brief Description:This position is primarily responsible for providing medical support to all operational functions within the Safety Department and Clinical Operations, and supporting the Safety Manager, the Associate Director, and the Executive Director/Director. ...

Requirements:

Brief Description:

This position is primarily responsible for providing medical support to all operational functions within the Safety Department and Clinical Operations, and supporting the Safety Manager, the Associate Director, and the Executive Director/Director.

Specific Job Duties:

  • Ensure that given timelines are met according to project and regulatory timelines
  • Process and evaluate AE reports according to the customer’s standard operating procedures (SOPs): write/review the narrative, perform seriousness rating and causality assessment 
  • Perform medical review of individual cases or safety reports
  • Perform ICSR signal/trend detection
  • Perform Aggregate line listing signal/trend detection
  • Review SAE and AE coding to ensure medical accuracy with the verbatim reported term
  • Ensures medical and scientific input in study protocols and safety reports
  • Write/participate in writing safety reports (RMPs, PSURs, ARs, SBRs, Issue workups, annual reports…)
  • Provide medical input and medical monitoring in the clinical development process.

Supervisory Responsibilities:

Some mentoring and training of staff required

Requirements:

  • Qualified MD, DO
  • At least 2 years clinical practice experience in drug safety in pharmaceutical, biotech or CRO preferred
  • Some direct clinical research experience is preferred
  • Knowledge of relevant regulation and legislation
  • Fluent in English; additional languages a plus
  • Excellent written and verbal communication skills
  • Good interpersonal and presentation skills
  • Strong computer skills

About UBC

United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety. While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management.

Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.

Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.

By combining insight from data, understanding patient behavior, and the science behind clinical specialties, we can help our clients make informed decisions and optimize the care given to patients using their therapies and products.

#LI-CD1

 

Apply for this job: Safety Physician

Contact Information:

Address:  United BioSource Corporation (UBC)
Europe Headquarters
26-28 Hammersmith Grove
London
United Kingdom
W6 7HA
England
Tel:  +44 (0)20 8834 0100
Website:  Visit Our Web Site

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