Senior Pharmaceutical Safety Expert

2 weeks ago

tiruchirappalli, India beBeePhysician Full time

Medical Safety Physician Job DescriptionWe are seeking a Medical Safety Physician to join our team. This is a key role in ensuring the safety and quality of our products.Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports.Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion.Perform triage of cases and determine seriousness and relatedness across products as assigned.Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrative.Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas.Escalate complex case issues on client product(s) to the medical review team of the client as appropriate.Conduct assessment of litigation cases across products as assigned.Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups.Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate.Acquire and maintain knowledge of applicable Global Health Authority regulations.Perform any other drug safety related activities as assigned.Required Skills and QualificationsThe ideal candidate will have:Experience with relevant safety databases and related software applications.Proven experience in customer handling and relationship.Proven ability to perform task management.Proven people management skills.Strong competence with medical and therapeutic terminology.Understanding of Patient Safety regulatory obligation.Good attention to detail.Ability to deliver within established timelines.Fluency in Spoken and written English and excellent comprehension.BenefitsThis role offers:Opportunities for professional growth and development.A dynamic and supportive work environment.A competitive salary and benefits package.OthersThis is a challenging and rewarding role that requires strong communication and analytical skills. If you are a motivated and results-driven individual who is passionate about patient safety, we encourage you to apply.

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