Literature Review Specialist
6 days ago
As a member of the Safety Operations Literature team, you will serve as a subject matter expert for individual case safety reporting. You will perform quality review of work performed by an outsource vendor and provide instruction and training as needed.
This role collaborates with others to review, rectify and reconcile data.
You will be responsible for supervising the quality of abstract review, article review, and individual cases processed by agencies through random QC of cases or through review of aggregate data.
- Supervise quality of abstract review, article review, and individual cases processed by agencies through random QC of cases or through review of aggregate data.
- Provide training to outsource vendors for Literature review and case processing, including new hire training and certification and ongoing training and feedback for existing vendor staff.
- Process literature adverse event reports as needed in a cross-functional team.
- Interface and collaborate with functional partners at our organization and with local and regional Patient Safety team members to facilitate global exchange of safety information.
- Participate in compliance supervising related activities, including CAPA and Quality Control Metrics.
We are seeking individuals with the following skills and qualifications:
- Bachelor's or Master's degree in Pharmacy
- Minimum 2 years patient care experience or equivalent AND minimum 1 year experience required as Safety Review Specialist or proficiency in a Global Safety Database (e.g., ARISg, Argus)
- Knowledge of multiple therapeutic areas
- Experience in pharmaceutical industry - Quality, Pharmacovigilance or Regulatory department
- Excellent analytical & problem-solving skills
- Excellent oral and written communication
- Collaborative interpersonal skills to cultivate a team environment
- Ability to work independently under deadlines and changing priorities
- Able to multitask and prioritize changing workload every day
- In-depth knowledge of worldwide and regional safety regulations
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