Medical Reviewer, Icsr

2 weeks ago

Bengaluru Karnataka, India ClinChoice Full time

ClinChoice 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).

**The Application Process**:
**Who will you be working for?**

**About ClinChoice**:
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare

**Our Company Ethos**:
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

**Key words**: Medical Reviewer, Medical Doctor, MD, MBBS, ICSR, GvP, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated

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