We are looking for a dynamic person to join our in-house team as a Literature Review Specialist on a permanent basis. You will work on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies.
Main Job Tasks and Responsibilities:
- Reviews literature for Client Consumer or Pharma products for safety information as detailed in applicable Client procedures and assess for potential ICSRs, signals and/or meeting PBRER-PSUR criteria and as required.
- Responsible for translation management and full text procurement, as detailed in applicable client procedures.
- Authors narratives/summaries/MAH comments as per client SOPs.
- Provides medical/safety support on all assigned Client Consumer or Pharma products.
- Escalates any identified ICSRs, PSUR relevance and potential signals to the Literature Review Physician and/or client within agreed timelines mandated by client procedures.
- Completes the assessment of literature references for aggregate reports within prescribed timelines.
- Accurately completes required documentation and verifiable data, then uploads to Client designated repository.
- Completes monthly tracker with details of assessments made within the client system/tools.
- Provides monthly metrics with accurate and verifiable data.
- Awareness and understanding of relevant GVP modules.
Education and Experience:
- MSc, BPharm, PharmD, MPharm with 2 years of Pharmacovigilance experience, including global literature monitoring.
- Experience in literature research and interpretation of safety data.
- Knowledge of international regulatory requirements and guidance (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and GVP).
- Training and mentoring skill (GVP concepts & its application).
- Must have basic hands-on experience with MS office applications (Outlook, Excel, Word, Power Point, etc)
