Qinecsa Solutions Hiring Senior Medical Safety Physician in Bangalore (Whitefield)
Qinecsa Solutions is hiring for a Senior Medical Safety Physician role, seeking candidates with 2-5 years of relevant experience as a Medical Reviewer. The role is onsite from the Bangalore Office (Whitefield). Qualification required: MBBS / MD.
Senior Medical Safety Physician Job Details
Company: Qinecsa Solutions
Job Title: Senior Medical Safety Physician
Experience: 2 – 5 years in Pharmacovigilance
Workplace Type: Onsite from Bangalore Office (Whitefield)
Job Description
Qinecsa Solutions is hiring a Senior Medical Safety Physician/Senior Drug Safety Physician with 2-5 years of relevant experience as a Medical Reviewer.
Key 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.
Eligibility Criteria
Education: MBBS / MD
Mandatory: MCI Registration/State Medical Council Registration
Experience: 2 – 5 years in Pharmacovigilance
Required Skills
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