Medical Writer II
Parexel
India - Telangana - Hyderabad
3d ago

Job Description

Perform Quality Review of Aggregate Reports (e.g. Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Risk Management Plans (RMPs) and Safety Assessment Reports (SARs), as required

Qualifications

  • Science / Medicine degree : The minimum qualification required would be a University degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics etc.)
  • A degree in Medicine / Dentistry / Physiotherapy / Experimental Medicine, which involves patient exposure in hospital based environment, would be an advantage
  • Should have a minimum 3 years of relevant experience in authoring and reviewing of aggregates reports (PSURS / PBRERs, DSURs, PADERs, SARs and RMPs).
  • If person has worked on innovator drugs then it would be an advantage

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