Principal Specialist, DSPV Operations

Neurocrine Biosciences • San Diego, CA

4h

About The Position

Neurocrine Biosciences is a leading biopharmaceutical company dedicated to discovering, developing, and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine, and immunological disorders. This role is a key contributor to the success of the Drug Safety and Pharmacovigilance (DSPV) department, working under the direction of the Manager and Director of DSPV Operations. The position provides support for oversight of case processing activities, signal detection activities, pharmacovigilance compliance activities, and safety system-related activities.

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.
• Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines.
• Works to improve tools and processes within functional area.
• Developing reputation inside the company as it relates to area of expertise.
• Ability to work as part of and lead multiple teams.
• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams.
• Excellent computer skills.
• Excellent communications, problem-solving, analytical thinking skills.
• Sees broader picture, impact on multiple departments/divisions.
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
• Excellent project management skills.
• 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.

Nice To Haves

• Vendor management experience preferred.

Responsibilities

• 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 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.
• Participate 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.

Benefits

• Retirement savings plan (with company match)
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Principal