Junior Medical Safety Physician

Qinecsa Solutions; Bengaluru; On-site; INR 500,000 - 750,000; Full time

Job summary

Qinecsa Solutions in Bengaluru is hiring a Medical Safety Physician to serve as a Medical Reviewer with 0-1 years of relevant Pharmacovigilance experience.

Key duties include reviewing safety reports from trials and spontaneous sources, determining reportability, triaging cases, assigning MedDRA codes, and staying current with global health authority regulations. This is an onsite role at the Bangalore office (Whitefield).

Qualifications

• MBBS/MD with suitable medical qualifications
• Mandatory MCI or State Medical Council registration
• 1–2 years in Pharmacovigilance or related pharmacovigilance experience
• Experience with safety databases and related software applications
• Strong customer handling and relationship management
• Good presentation skills and ability to present to groups
• Knowledge of Life Sciences industry and drug life cycle
• Relevant product and industry knowledge

Responsibilities

• Review and assess individual case safety reports from clinical trials, spontaneous and solicited reports
• Determine regulatory reportability of cases within the therapeutic team and across products/sites
• Perform case triage and assess seriousness and relatedness across products
• Verify MedDRA coding, labeling considerations and narrative accuracy
• Maintain current knowledge of product portfolios and safety profiles
• Escalate complex issues to client medical review teams when needed
• Assess litigation cases across products as assigned
• Coordinate with client teams to resolve case issues
• Communicate effectively within and across client therapeutic teams
• Maintain knowledge of applicable global health authority regulations
• Perform other drug safety activities as assigned

Skills

Pharmacovigilance

Medical Reviewer

English communication

Education

MBBS / MD

MCI Registration

Job description

We are Hiring Medical Safety Physicians/Drug Safety Physicians with 0-1 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 - 2 years in Pharmacovigilance

Workplace Type: Onsite from Bangalore Office (Whitefield)

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.
• 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
• 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