- Excellent employment opportunity for a Triage Manager in the Ridgefield, CT area.
- Directly responsible for ensuring that adverse events are processed, analyzed and reported according to Corporate SOPs, local working instructions and local regulatory requirements.
- Makes sure that adverse event cases contain complete medical information and are processed in a timely manner for submission to authorities as per federal regulations.
- Requests additional information from adverse event reporters where necessary in order to provide a complete medical story for the case.
- Responsible for distribution and retrieval of data to internal and external customers as needed for analysis and compliance with regulations.
- Serve as point of contact with clinical team in areas of adverse events process.
- Bachelors' Degree or higher Nursing, Pharmacy or related Health Care field (required).
- Pharmaceutical Industry experience.
- Must possess solid understanding of federal regulations as they apply to drug surveillance for both IND and NDA reporting.
- Excellent communication skills required in order to facilitate report preparation, participate in working groups and interact with a variety of departments.
- Ability to make decisions independently, accountable for decisions made.
- Experience with computerized data entry and retrieval as well as other computer-based applications (Word/Excel) is also required.