Medical Safety Physician

Qinecsa Solutions · India

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