Medical Safety Physician

2 days ago


Delhi, 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 Physician Qualifications Education: MBBS / MD Mandatory: MCI Registration/State Medical Council Registration Experience: 1 - 3 years in Pharmacovigilance Primary Responsibilities As a medical reviewer - Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports - 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 - Perform triage of cases and 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 - Conduct assessment of litigation cases across products as assigned - 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. 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. - 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 Responsibilities - strong competence with medical and therapeutic terminology - Understanding of Patient Safety regulatory obligation - Good attention to detail - Ability to deliver within established timelines - Fluency in Spoken and written English and excellent comprehension. Additional Skills: - Strong motivational skills and abilities, promoting a team-based approach - Strong interpersonal and communication skills, both verbal and written - Strong organizational and leadership skills - Goal-oriented - Ability to maintain professional and positive attitude



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