Literature Review Physician
6 months ago
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 Literature Review Physician 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**:
- Reviews literature for Client Consumer or Pharma products for safety information as detailed in applicable Client procedures and assess for potential ICSRs, signals and/or meeting PBRER-PSUR criteria and as required.
- Provides medical/safety support on all assigned Client Consumer or Pharma products.
- Escalates any potential signals to the relevant stakeholders after identification andwithin timelines as mandated by client procedures.
- Completes the assessment of literature references for aggregate reports within prescribed timelines.
- Performs quality review (as applicable) of literature articles including documentation of inclusion /exclusion criteria of ICSR, potential signals and PSUR relevance.
- Reviews case summaries/narratives/MAH comments etc.
- Accurately completes required documentation andverifiable data, then uploads to Client designated repository.
- Provides medical assessment support to the team, as needed.
- Provides support to client physicians on literature related enquiries.
- Completes monthly tracker with details of assessments made within the client system/tools.
- Provides monthly metrics with accurate andverifiable data.
- Awareness and understanding of relevant GVP modules.
**Education and Experience**:
- Experience in literature research and interpretation of safety data.
- Knowledge of international regulatory requirements and guidance (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and GVP).
- Training and mentoring skill (GVP concepts & medical aspects).
**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**: Literature Review, Literature Review Physician, CRO, Contract Research Organisation
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