Qinecsa Solutions
Website:
qinecsa.com
Job details:
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.
- 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
Click on Apply to know more.
