Medical Safety Physician

1 day ago

Mysuru, India Qinecsa Solutions Full time

We are Hiring Medical Safety Physicians/Drug Safety Physicians with 1-3 years of relevant experience as a Medical Reviewer.Job Title: Medical Safety PhysicianQualificationsEducation: MBBS / MDMandatory: MCI Registration/State Medical Council Registration Experience: 1 - 3 years in PharmacovigilancePrimary ResponsibilitiesAs a medical reviewerConduct review 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 narrative.Acquire 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 assigned.Specialized knowledge and skills:Experience with relevant safety databases and related software applicationsProven experience in customer handling and relationship.Proven ability to perform task management.Proven people management skills.Must have good presentation skills and the ability to give presentations.Knowledge of the Life Sciences Industry and life cycle of drug.Relevant product and industry knowledge.Secondary Responsibilitiesstrong 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 comprehension.Additional Skills:Strong 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 attitude

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