Drug Safety Case Manager
Camden Metro Area, NJ
- The Drug Safety Case Manager works in a team-oriented environment and is responsible for the overall processing of adverse event information in compliance with applicable FDA and global regulations and Standard Operating Procedures (SOPs) and guidelines.
Primary responsibilities include the following. Other duties may be assigned.
- Ensures accurate data entry and the timely processing of adverse event reports including writing meaningful clinical case narratives.
- Create queries for adverse event report clarification.
- Perform quality control of adverse event information processed in the safety database.
- Schedule expedited reports to health authorities to insure timely ICSR regulatory reporting requirement compliance.
- Track adverse event information and prepare administrative reports for management.
- Assist in developing and maintaining standard global procedures and guidelines for Drug Safety operations.
- Review, evaluate and assess adverse event information for regulatory reporting.
- Assist in the preparation of internal and external reports including metric reports and aggregate reports per US and international regulations.
- Create and generate safety information for internal use, and safety review boards.
- Interact with other Drug Safety Units in the review, processing, and reporting of safety information.
- Participate in/attend clinical team meetings when appropriate, provide technical advice and support to the clinical team.
- Represent Drug Safety Department in other company team meetings or conferences.
- Contribute to inspection readiness planning, as needed.
- Participates in Safety Operations training initiatives.
- Assists with special projects.
REQUIRED QUALIFICATIONS AND EXPERIENCE
- Bachelor s degree (or comparable non-US Degree) in Pharmacy, Nursing or related health field.
- Minimum of two years experience in Drug Safety case management.
- General knowledge of MedDRA coding and drug dictionaries.
- Detailed knowledge of FDA and familiarity with international regulatory safety reporting requirements
- 1-2 years post-graduate clinical experience in hospital or clinical practice setting.
- Knowledge of safety database systems.