Medical consultant

Job Description:

Responsibilities

•  Manage all medical aspects of contracted pharmacovigilance tasks across the pharmaceutical product life cycle.
•  Adhere to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues, as well as client SOPs/directives, project-specific WPDs for assigned projects, and the organization’s corporate policies and SOPs/WPDs.
•  Provide medical consultation to team members and communicate clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
•  Provide therapeutic and protocol training on assigned studies, as requested.
•  Assist in writing (interpretation of safety data) and/or reviewing the safety portion of the CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules; scientifically review aggregate reports, contribute to label updates, review and assess literature, and support dossier maintenance and risk management activities to ensure that the medical content is accurate and complete.
•  Provide medical review of cases and perform reviews of adverse events of special interest and serious adverse events.
•  Perform data reviews as specified in the client contract and data validation manual, including review of coding listings and/or full safety data to assess potential safety concerns. Medically review adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc.) as contracted.

Qualification & Experience

•  MD or equivalent or MBBS (with 2 years of clinical experience) required. Active medical licensure preferred.