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Job Details


Company: Advanced Clinical Recruitment Ltd
Reference: JC3
Closing Date: 16 Mar 17
Type: Full Time
Salary (£): Competitive

Job Summary:

If you would like to find out more information regarding this opportunity, please either call me directly on (0044) 114 294 5005 or alternatively email me on


The Safety Physician provides medical expertise to the medical information and vigilance department, in both clinical trials and post-marketing. Contributes to the analysis, review and approval of Individual Case Safety Reports (ICSR) and Periodic Reports for marketed and investigational products. Maintains active pharmacovigilance oversight for products including accurate signal detection and provides medical input to the generation and review of risk management.

Key responsibilities:

  • Reviews all appropriate safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature).
  • Conducts medical assessment of all safety related data (AEs, SAE, SUSAR, AESI etc.).
  • Ensures medical accuracy of case narratives, coding and medical sense of all cases and ensures appropriate queries are raised to expedite case closure.
  • Writes safety section, including benefit risk assessment of all aggregate safety reports such as Periodic Drug Safety Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), DSUR/IND Annual reports and line listings of Suspected Unexpected Serious Adverse Reactions (SUSARs) for regulatory submission.
  • Prepares and may present product safety issues at meetings, both internal and external.
  • Authors/reviews relevant sections of all aggregate safety reports and ensures the overall quality of documents.

Minimum Requirements:

  • Medical degree and a high level of medical competence
  • Minimum 2 years of prior experience in Pharmacovigilance and medical writing

Additional Desirable Skills:

  • A thorough working knowledge of clinical research and global regulatory requirements and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities
  • Good organizational and prioritization skills
  • Good interpersonal skills (i.e. team player)
  • Working knowledge of MedDRA
  • Flexibility and ability to adapt and learn quickly
  • Ability to work under pressure and to tight deadlines
  • Excellent communication and presentation skills in English (both written and spoken)


Apply for this job: SAFETY PHYSICIAN

Contact Information:

Address:  Head Office
Regus 2nd Floor
The Portergate
Eccleshall Road
S11 8NX
Tel:  0114 270 1741
Website:  Visit Our Web Site

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