Chief Medical Safety Officer

3 days ago

bangalore, India beBeeDrugSafety Full time

We are looking for a Medical Reviewer with 1-3 years of relevant experience.Job Title: Drug Safety PhysicianKey ResponsibilitiesReview and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reportsDetermine 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 fashionPerform triage of cases and determine seriousness and relatedness across products as assignedReview and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrativeAcquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areasEscalate complex case issues on client product(s) to the medical review team of the client as appropriateConduct assessment of litigation cases across products as assignedIdentify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groupsCommunicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriateAcquire and maintain knowledge of applicable Global Health Authority regulationsPerform any other drug safety related activities as assignedRequired Skills and QualificationsExperience with relevant safety databases and related software applicationsProven experience in customer handling and relationshipProven ability to perform task managementProven people management skillsMust have good presentation skills and the ability to give presentationsKnowledge of the Life Sciences Industry and life cycle of drugRelevant product and industry knowledgeBenefitsStrong competence with medical and therapeutic terminologyUnderstanding of Patient Safety regulatory obligationGood attention to detailAbility to deliver within established timelinesFluency in Spoken and written English and excellent comprehensionAdditional RequirementsStrong motivational skills and abilities, promoting a team-based approachStrong interpersonal and communication skills, both verbal and writtenStrong organizational and leadership skillsGoal-orientedAbility to maintain professional and positive attitudeThe ideal candidate should possess strong analytical skills, attention to detail, and effective communication skills. The selected candidate will be working closely with our team to ensure seamless delivery of projects. If you're passionate about Drug Safety and willing to learn, we encourage you to apply.

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