Medical Reviewer

Acorn Regulatory have a part-time Medical Review position available in our Pharmacovigilance division. Part-time and structured around remote working.  This role provides excellent flexibility while working with an award winning and highly experienced team.

Knowledge and Skills

• Physician (MD or equivalent)
• Strong commercial awareness & an innate ability to assess the commercial implications of decisions & advice.
• A minimum of 3 years’ experience in industry, academia or patient care settings.
• Experience with global pharmacovigilance legislation.
• Previous experience performing medical review of ICSR and/or safety data is required
• Clinical report writing for medicinal products and medical device submissions.
• The attitude and ability to be effective in a lean, small company environment.
• Above average communication skills both written and oral, with the ability to influence at a senior level.

Purpose/Key responsibilities

Pharmacovigilance / Device Vigilance:

• Medical evaluation and assessment of suspect Individual Case Safety Reports (ICSR’s) reported to Acorn Regulatory for causality / seriousness and expectedness as per current PV requirements for the PV Department.
• Assist with the review of Risk Management Plans (RMP’s), Signal Detection Reports, Periodic Safety Update Report’s (PSURs) and other PV documents for the PV Dept.
• Review and support to clinical overview report writing for submission in marketing authorisation applications.
• Review of medical and scientific materials, including educational materials, when required
• Deliver product training to Acorn employees and clients where applicable.