18 Sep
|
Qinecsa Solutions
|
Sangli
18 Sep
Qinecsa Solutions
Sangli
Job Description
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 reportsn
- 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 fashionn
- Perform triage of cases and determine seriousness and relatedness across products as assignedn
- Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrative.n
- Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areasn
- Escalate complex case issues on client product(s) to the medical review team of the client as appropriaten
- Conduct assessment of litigation cases across products as assignedn
- Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groupsn
- Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriaten
- Acquire and maintain knowledge of applicable Global Health Authority regulationsn
- Perform any other drug safety related activities as assigned.n
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nSpecialized knowledge and skills :
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- Experience with relevant safety databases and related software applicationsn
- Proven experience in customer handling and relationship.n
- Proven ability to perform task management.n
- Proven people management skills.n
📌 Medical Safety Physician (Sangli)
🏢 Qinecsa Solutions
📍 Sangli