Medical Safety Physician at Qinecsa Solutions, Bangalore
Qinecsa Solutions is hiring Medical Safety Physicians/Drug Safety Physicians as Medical Reviewers, onsite from its Bangalore Office (Whitefield). This Medical Safety Physician opportunity requires an MBBS / MD and MCI Registration/State Medical Council Registration.
Job Details
Company: Qinecsa Solutions
Job Title: Medical Safety Physician
Workplace Type: Onsite from Bangalore Office (Whitefield)
Medical Safety Physician Job Description
We are Hiring Medical Safety Physicians/Drug Safety Physicians with 0-1 years of relevant experience as a Medical Reviewer.
Key Responsibilities
As a medical reviewer
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Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports
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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
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Perform triage of cases and determine seriousness and relatedness across products as assigned
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Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrative.
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Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas
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Escalate complex case issues on client product(s) to the medical review team of the client as appropriate
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Conduct assessment of litigation cases across products as assigned
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Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups
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Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate
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Acquire and maintain knowledge of applicable Global Health Authority regulations
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Perform any other drug safety related activities as assigned.
Secondary Responsibilities
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strong competence with medical and therapeutic terminology
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Understanding of Patient Safety regulatory obligation
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Good attention to detail
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Ability to deliver within established timelines
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Fluency in Spoken and written English and excellent comprehension.
Eligibility Criteria
Education: MBBS / MD
Mandatory: MCI Registration/State Medical Council Registration
Experience: 1 – 2 years in Pharmacovigilance. This Medical Safety Physician role requires the stated relevant experience.
Required Skills
Specialized knowledge and skills
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Experience with relevant safety databases and related software applications
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Proven experience in customer handling and relationship.
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Proven ability to perform task management.
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Proven people management skills.
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Must have good presentation skills and the ability to give presentations.
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Knowledge of the Life Sciences Industry and life cycle of drug.
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Relevant product and industry knowledge.
Additional Skills
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Strong motivational skills and abilities, promoting a team-based approach
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Strong interpersonal and communication skills, both verbal and written
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Strong organizational and leadership skills
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Goal-oriented
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Ability to maintain professional and positive attitude