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Medical Reviewer
Eversana
posted 5mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
The most important aspect of this position is to perform medical review, evaluation, and analysis of Individual Case Safety Reports (ICSRs), assisting clients with the safety data, compliance with pharmacovigilance (PV) legislation and guidance, and all medical aspects of PV.
KEY FOR THIS ROLE
- Perform medical review of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality, and company summary within the stipulated time to comply with service level agreements and regulatory timelines.
- Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements.
- Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported.
- Deep understanding of the scientific basis for therapies and drug-induced diseases. Knowledge of medical device, vaccines and drug development process;
- Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas.
- Involve in process improvement activities such as implementation of quality control process.
- Provide timely feedback to case processors on the errors/discrepancies noted.
- Assist in training/mentoring of other case processing/medical review personnel as necessitated.
- Participate in organizational activities to meet objectives suitable for the role/area of expertise.
- Maintain awareness of medical-safety-regulatory industry developments
EXPECTATIONS OF THE JOB
- (% or number of days)
- 45 Hours (Hours per week, days of the week)
The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position.
An individual in this position must be able to successfully perform the expectations listed above.
EDUCATION AND EXPERIENCE
The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.
- MBBS/MD/BDS/MDS
- 1-2 years of experience as Medical Reviewer for ICSRs in pharmaceutical, biotech, medical device. CRO experience highly desirable.
- Regulatory guidelines expertise knowledge of international guidelines and country specific regulatory requirements (FDA, ICH GCP, MHRA, Pharmaceuticals and Medical Devices Agency (PMDA), GVP Modules; respective EU Clinical Trial Directive etc.)
- Excellent interpersonal and organizational skills. Excellent written and verbal communication skills.
- Must have hands on experience with MS Office applications (Outlook, Excel, Word, PowerPoint, etc.).
Employment Type: Full Time, Permanent
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What people at Eversana are saying
Rating based on 1 Medical Reviewer
review
Anonymous · Other
Likes
Previous leadership n my team
Dislikes
New leadership n politics
- Salary - Poor
+6 more
Medical Reviewer salary at Eversana
reported by
3
employees
with 6-12
years exp.
₹12
L/yr - ₹21
L/yr
93%
more
than the average Medical Reviewer Salary in India
View more details
What Eversana employees are saying about work life
based on 169 employees
Flexible timing
Monday to Friday
No travel
Day Shift
Eversana Benefits
View more benefits
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