Medical Reviewer
4 weeks ago
Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA.
Job Description
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 Responsibilities 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
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.).
Additional Information
All your information will be kept confidential according to EEO guidelines.
Our team is aware of recent fraudulent job offers in the market, misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites, unsolicited e-mails, or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA.
From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility.
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