Medical Reviewer

Medical Reviewer

• Responsible for Medical review of Company and Literature and Regulatory cases
• Appropriate selection of adverse events and assessment of seriousness criteria
• MedDRA Coding of the adverse events
• Review of reporter/company causality and Label assessment
• Selection of product role (suspect, concomitant or interacting) and concomitant conditions, medical history, and laboratory data
• Case Narrative evaluation
• Drafting/Quality/Medical review of aggregate reports (Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs)
• Medical review of Risk Management Plans (RMPs)
• Medical review of Signal Management Reports

Preferred candidate profile

• MBBS or MD doctor in Pharmacology

• Author Medical Writing tasks including aggregate reports Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), RMPs and other documents needed throughout the products life cycle
• Responsible for the quality and content of the document, and quality control review of documents prepared by Medical Writing peers
• Continuous self-education in all aspects associated with Medical Writing activities
• Active participation in trainings, maintenance, and development of quality system documents
• Support in all PV operations associated with Medical Writing

Preferred candidate profile

• PharmD or M. Pharmacy
• Previous experience of drug safety medical writing, including Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Risk Management Plans (RMPs) and Signal management Reports
• Time management, organisation and multitasking skills with good attention to detail
• Strong communication and presentation skills
• Advanced knowledge of MS Office
• Fluency in English