Chief Medical Safety Strategist

2 days ago

shimoga, India beBeeMedical Full time

Senior Medical Safety AdvisorWe are seeking a seasoned Senior Medical Safety Advisor to join our team.As a key member of our safety team, you will be responsible for the expert medical evaluation of safety data from various sources for pharmacovigilance purposes.You will assess the scientific relevance of serious adverse events in the product's safety profile and therapeutic area.Responsibilities:Conduct thorough medical reviews of trial-related Adverse Events and post-marketing adverse drug reactions.Compose and edit Analyses of Similar Events for expedited cases, ensuring timely delivery.Coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications, or other medical data listings to ensure accuracy and consistency.Provide internal consultation to pharmacovigilance case processing teams on projects, offering expert guidance and support.Perform medical safety reviews of protocols, Investigative Brochures, and/or Case Report Forms to ensure compliance with regulatory requirements.Aggregate reviews of safety information, including clinical data, post marketing, literature review, and observational studies to identify potential risks and benefits.Evaluate and maintain service delivery, compliance, and quality within regulatory/contracted timelines.Lead and manage safety team members in single case assessment, providing coaching and support as needed.Update watch lists, expectedness, labeling lists, and RSIs for assigned products, staying up-to-date with the latest regulatory requirements.Develop and lead training activities, product transitions, audit preparation, and knowledge exchange initiatives to enhance team performance.Review and sign off on Project Safety Plans and Medical Monitoring Plans, ensuring alignment with company policies and procedures.Present safety and clinical data review findings during client meetings, effectively communicating complex information.Act as Lead Safety Physician or additional team support, providing medical escalation support for EU Qualified Persons for Pharmacovigilance projects as needed.Provide 24-hour medical support on assigned projects, responding promptly to emerging issues.Stay current with medical safety-regulatory industry developments, applying this knowledge to inform decision-making.Support and participate in signal detection efforts, contributing to the identification of potential safety signals.

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    shimoga, India beBeeMedical Full time

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