Lead Medical Reviewer

Job Description

We are currently seeking a Lead Medical Reviewer to join our growing team. Within this role you will be responsible for Medical Review activities including:

• The medical review of all ICSR cases from both CT and PM studies
• Ensuring completeness of the data according to applicable regulations and guidelines, SOP, and project specific guidelines
• Conducting the review and assessment of SARs and SUSARs received from sites
• Determining regulatory reportability of cases obtained from clinical trials, within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion
• Performing the triage of cases and determine seriousness and relatedness across products as assigned
• Reviewing and verifying appropriate selection of adverse events from source documents, assigning appropriate MedDRA code of medical history, Laboratory tests and events, assessing expectedness, reviewing narrative, and editing queries as appropriate that provides medical judgement
• Reviewing analysis of similar events (AOSE) listings and narrative as applicable
• Acquiring and maintaining current knowledge of product portfolio and safety profiles for products across therapeutic areas
• Escalating complex case issues on client product(s) to the medical review team of the Client as appropriate
• Conducting assessment of litigation cases across products as assigned
• Identifying and resolving case issues, coordinating with client therapeutic teams/site for specific products or functional groups
• Communicating and interacting effectively within and across all clients therapeutic teams, and within functional team management as appropriate
• Attending project meetings and client meetings as requested
• Making sure all training is executed in a timely manner and is documented
• Making sure all the cases are prioritized according to the Safety management plan timelines and regulatory timelines
• Completing allocated cases on a day-to-day basis
• Communicating with delivery leads/designee for any correction required in the cases or any trends observed

Desirable Skills and Experience

• Good understanding of medical and therapeutic terminologies
• In depth knowledge of applicable global, regional, and local clinical regulatory requirements i.e. Good Clinical Practice (GCP) and Internation conference on Harmonisation (ICH) guidelines
• Understanding of patient safety regulatory obligations
• Should be familiar with regulatory and pharmacovigilance guidelines
• Good command of written and spoken English; additional languages favourable
• Good knowledge of usual office software (MS Office: Word, Excel, Power point)
• Soft skills (motivation, strong communication competence, structured in work, organizing skills, reliability, commitment, and capacity for teamwork)

Bangalore, India

MBBS or MD, has completed a Board certification and/or relevant higher medical training

Senior

Pharmacovigilance and Safety

Full Time