Principal Specialist – Safety
| Company | Neurocrine Biosciences |
|---|---|
| Location | San Diego, CA, USA |
| Salary | $128200 – $185900 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PharmD, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- BS/BA degree in related scientific field and 6+ years of relevant experience OR
- Master’s degree and 4+ years of related experience OR
- PharmD or PhD and 2+ years of related experience
- Strong knowledge of ICH guidelines, US and EU pharmacovigilance regulatory requirements
- Experience and knowledge of drug safety systems (Argus preferred)
- Strong knowledge of current pharmacovigilance practices
- Team player with ability to function in a multi-disciplinary environment
- Self-motivated, detail oriented, and able to prioritize and plan effectively
- Excellent computer skills
- Excellent communications, problem-solving, analytical thinking skills
- Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
- Excellent project management skills
Responsibilities
- Provide oversight on outsourced safety-related functions.
- Perform adequate case reviews for cases that are processed by PV Case processing Vendor and provide guidance as needed.
- Manage expedited reporting of SAEs from Clinical Trials, including preparation of analysis of similar events as needed.
- Support the generation of periodic safety reports in accordance with regulatory requirements and standard operating procedure.
- Support signal detection and evaluation activities in accordance with SOPs and guidelines.
- Participates in developing and updating DSPV Operations SOPs and guidelines and provides staff training.
- Act as liaison to vendor for case processing activities and ensures adherence to NBI processes and regulatory requirements.
- Support Study Start up activities including but not limited to development of training documents for new studies, review of study specific safety management plans (SMPs).
- Support Pharmacovigilance compliance related activities including but not limited to Submission compliance report generation, tracking of vendor deviations, CAPAs etc.
- Support safety database validation activities involving but not limited to review of validation documents, perform validation testing for safety system changes if needed, collaborate with IT and system administrator for system updates.
- Contribute to inspection readiness related activities as needed.
- May perform other duties as needed.
Preferred Qualifications
- Vendor management experience preferred