Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary
Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements
Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data
Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable
Provide aggregate reviews of safety information, including but not limited to clinical data, postmarketing, literature review and observational studies to maintain oversight of a products safety profile (e
g: DSUR, RMP, PBRER, ad hoc regulatory reports etc)
Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines
Lead and participate in the initiatives taken for the same from team delivery perspective
Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment, Ensure update of watch list, list of expectednsess, labeling list/RSIs etc for the assigned products and develop such additional capabilities within the team
Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives
Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable
Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable
Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable
Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable
24 hour medical support as required on assigned projects
Maintain awareness of medical safety-regulatory industry developments
Provide support and participate in signal detection efforts, e-g strategy meetings etc as applicable
Qualifications
Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education
Req
Three (3 years) experience practicing clinical medicine after award of medical degree
Graduate, and/or Residency training can qualify for clinical practice experience Req
Two (2) years of pharma experience Pref
Sound knowledge of Medicine
In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i-e, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Knowledge of PharmacovigilanceICSR and Aggregate reports
In-depth knowledge of departmental standard operating procedures (SOPs)
Skill in use of multiple safety databases
Adequate Computer skills, especially Microsoft word, excel & PowerPoint
Good communication skillsverbal and written

Senior Medical Safety Advisor

Job Description

Required Skills