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This employer requests that only candidates in India apply to this job.
You appear to be located in United States, not India, so you will not be able to apply for this job.
Bioclinica is hiring MBBS / MD candidates with or without Clinical / Non Clinical experience. Candidates interested in pursuing a career in Drug safety / Pharmacovigilance are invited to apply.
JOB TITLE: DRUG SAFETY PHYSICIAN
EDUCATION: MBBS/MD (IN ANY DISCIPLINE)
EXPERIENCE : ANY CLINICAL / NON CLINICAL EXPERIENCE
ESSENTIAL DUTIES AND RESPONSIBILITIES:
As a Medical Reviewer
Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports
Determine regulatory report ability 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
Determine seriousness and relatedness across products as assigned
Review 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 areas
Escalate complex case issues on client product(s) to the medical review team of the client as appropriate
Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups
Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate
Acquire and maintain knowledge of applicable Global Health Authority regulations
Perform any other drug safety related activities as assigned
Participate in internal and external audits and inspections by clients and health authorities
SPECIALIZED KNOWLEDGE AND SKILLS:
Experience with relevant safety databases and related software applications
Proven experience in customer handling and relationship.
Proven ability to perform task management.
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.