We are Hiring Medical Safety Physicians/Drug Safety Physicians with 1-3 years of relevant experience as a Medical Reviewer.

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nJob Title: Medical Safety Physician

nQualifications

nEducation: MBBS / MD

nMandatory: MCI Registration/State Medical Council Registration

nExperience: 1 - 3 years in Pharmacovigilance

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nPrimary Responsibilities

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nAs 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.
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nSpecialized 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.
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nSecondary 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.
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nAdditional Skills:

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- Strong motivational skills and abilities, promoting a team-based approach
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- Robust 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
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📌 Medical Safety Physician (Gurugram)
🏢 Qinecsa Solutions
📍 Gurugram