About the job
CliniResource is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Medical Reviewer on a permanent basis. You will work on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies.
Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!
Main Job Tasks and Responsibilities:
- Awareness and understanding of relevant GVP modules.
- Perform medical review of non-serious and serious ICSRs with emphasis on seriousness, expectedness, causality & narrative, etc. without missing on quality & compliance.
- Experience of medical review of ICSRs received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials.
- Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology, Neuroscience, Rare diseases, etc.
- Support 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 labelling and review narrative.
- 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 medical guidance and expert opinion on the cases to the data entry associates and quality reviewers to help resolve queries.
- Identify and resolve case issues, coordinate with client therapeutic teams and within functional team and manage as appropriate.
- Maintain Pharmacovigilance expertise and understanding of international safety regulations and guidelines.
- Responsible for completing the medical review activities in the safety database within the stipulated time to comply with service level agreements and regulatory timelines.
- Provide timely feedback to case processors on the errors/discrepancies noted.
- Assist in training/mentoring of other case processing/medical review personnel as necessitated.
- Adapt to different client case processing conventions and multi-task as per business needs.
- Perform ad-hoc tasks as advised by the team lead/manager with quality and compliance as per project requirement.
- Participate in organizational activities to meet objectives suitable for the role/area of expertise.
Education, Experience and Skills:
- Should be a MBBS/MD with 2- 4 years of experience as Medical Reviewer for ICSRs.
- Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements.
- Training and mentoring skill (GVP concepts & medical aspects such as disease condition, product portfolio, etc).
- Must have hands on experience with MS Office applications (Outlook, Excel, Word, PowerPoint, etc.).
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.