Medical Safety Physician

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