Principal Specialist, DSPV Operations
Neurocrine Biosciences
3 months ago
Remote friendly (San Diego, CA)
United States
Operations
About The Role
Key contributor to the success of the Drug Safety and Pharmacovigilance (DSPV) department. Works under the direction of the Manager and Director of DSPV Operations on DSPV Operations activities. Supports oversight of case processing, signal detection, pharmacovigilance compliance, and safety system-related activities.
Your Contributions
- Provide oversight on outsourced safety-related functions
- Perform adequate case reviews for cases processed by the PV Case processing vendor and provide guidance as needed
- Manage expedited reporting of SAEs from Clinical Trials, including analysis of similar events as needed
- Support generation of periodic safety reports in accordance with regulatory requirements and SOPs
- Support signal detection and evaluation activities per SOPs and guidelines
- Participate in developing/updating DSPV Operations SOPs and guidelines; provide staff training
- Liaison to the vendor for case processing activities; ensure adherence to NBI processes and regulatory requirements
- Support study start-up activities (e.g., training documents; review study-specific safety management plans)
- Support pharmacovigilance compliance (e.g., submission compliance report generation, tracking vendor deviations, CAPAs)
- Support safety database validation (review validation docs; perform validation testing for safety system changes; collaborate with IT)
- Contribute to inspection readiness as needed
- May perform other duties as needed
Requirements
- BS/BA in related scientific field + 6+ years relevant experience OR Master’s + 4+ years OR PharmD/PhD + 2+ years
- Knowledge of best practices in the functional discipline
- Ability to improve tools/processes; develop reputation in expertise area
- Ability to work as part of and lead multiple teams; leadership skills
- Excellent computer skills
- Excellent communications, problem-solving, analytical thinking
- Strong project management; meet multiple deadlines with accuracy/efficiency
- Strong knowledge of ICH guidelines and US/EU pharmacovigilance regulatory requirements
- Experience with drug safety systems (Argus preferred) and strong knowledge of current pharmacovigilance practices
- Team player in a multi-disciplinary environment; self-motivated, detail-oriented; prioritize/plan effectively
- Vendor management experience preferred
Compensation/Benefits
- Annual base salary: $130,800.00–$179,000.00; annual bonus target 30% of earned base salary; equity long-term incentive eligibility
- Benefits include retirement savings plan (company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health benefits (medical/prescription drug/dental/vision)
Application Instructions
- Apply even if your experience/qualifications don’t line up exactly with the job description.
Key contributor to the success of the Drug Safety and Pharmacovigilance (DSPV) department. Works under the direction of the Manager and Director of DSPV Operations on DSPV Operations activities. Supports oversight of case processing, signal detection, pharmacovigilance compliance, and safety system-related activities.
Your Contributions
- Provide oversight on outsourced safety-related functions
- Perform adequate case reviews for cases processed by the PV Case processing vendor and provide guidance as needed
- Manage expedited reporting of SAEs from Clinical Trials, including analysis of similar events as needed
- Support generation of periodic safety reports in accordance with regulatory requirements and SOPs
- Support signal detection and evaluation activities per SOPs and guidelines
- Participate in developing/updating DSPV Operations SOPs and guidelines; provide staff training
- Liaison to the vendor for case processing activities; ensure adherence to NBI processes and regulatory requirements
- Support study start-up activities (e.g., training documents; review study-specific safety management plans)
- Support pharmacovigilance compliance (e.g., submission compliance report generation, tracking vendor deviations, CAPAs)
- Support safety database validation (review validation docs; perform validation testing for safety system changes; collaborate with IT)
- Contribute to inspection readiness as needed
- May perform other duties as needed
Requirements
- BS/BA in related scientific field + 6+ years relevant experience OR Master’s + 4+ years OR PharmD/PhD + 2+ years
- Knowledge of best practices in the functional discipline
- Ability to improve tools/processes; develop reputation in expertise area
- Ability to work as part of and lead multiple teams; leadership skills
- Excellent computer skills
- Excellent communications, problem-solving, analytical thinking
- Strong project management; meet multiple deadlines with accuracy/efficiency
- Strong knowledge of ICH guidelines and US/EU pharmacovigilance regulatory requirements
- Experience with drug safety systems (Argus preferred) and strong knowledge of current pharmacovigilance practices
- Team player in a multi-disciplinary environment; self-motivated, detail-oriented; prioritize/plan effectively
- Vendor management experience preferred
Compensation/Benefits
- Annual base salary: $130,800.00–$179,000.00; annual bonus target 30% of earned base salary; equity long-term incentive eligibility
- Benefits include retirement savings plan (company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health benefits (medical/prescription drug/dental/vision)
Application Instructions
- Apply even if your experience/qualifications don’t line up exactly with the job description.