Senior Medical Safety Physician

Qinecsa Solutions; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Qinecsa Solutions in Bengaluru is hiring a Senior Medical Safety Physician (Medical Reviewer) with 2–5 years of pharmacovigilance experience. The role requires MBBS/MD and MCI/State Medical Council registration, onsite from the Bangalore office (Whitefield).

The medical reviewer will review safety reports, determine reportability, perform case triage, assign MedDRA codes, and maintain knowledge of product safety profiles while coordinating with client teams and regulatory bodies.

Qualifications

• MBBS or MD degree required; MCI/State medical council registration mandatory.
• 2–5 years of pharmacovigilance experience.
• Onsite Bangalore Office (Whitefield) workplace.

Responsibilities

• Review and assess individual case safety reports from trials and spontaneous/ solicited reports.
• Determine regulatory reportability within the assigned therapeutic team and across sites.
• Perform triage of cases and assess seriousness and relatedness.
• Verify selection of adverse events, assign MedDRA codes, and review labeling.
• Maintain knowledge of product portfolio and safety profiles.
• Escalate complex cases to client medical review team as appropriate.
• Coordinate with client teams to resolve case issues across products/sites.
• Stay updated on applicable Global Health Authority regulations.

Skills

Pharmacovigilance

Medical review

Regulatory knowledge

English communication

Education

MBBS / MD

Tools

Safety databases

Job description

We are Hiring Senior Medical Safety Physicians/Senior Drug Safety Physicians with 2-5 years of relevant experience as a Medical Reviewer.

Job Title: Senior Medical Safety Physician

Qualifications

Education: MBBS / MD

Mandatory: MCI Registration/State Medical Council Registration

Experience: 2 - 5 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