Sr. Specialist, DSPV Operations

Neurocrine Biosciences • San Diego, CA

5d

About The Position

Supports Pharmacovigilance (PV) Compliance activities and the continued development and maintenance of Neurocrine’s pharmacovigilance quality management system. Supports global pre- and post-marketing safety compliance activities, including compliance monitoring, quality issue management, inspection readiness, procedural document management, training, and maintenance of key PV compliance documentation.

Requirements

• BS/BA in a scientific field or RN degree AND 4+ years in drug safety in the biotech/pharmaceutical industry with 2+ years of pharmacovigilance compliance experience.
• Strong knowledge of ICH guidelines, US and EU pharmacovigilance regulatory requirements
• Knowledge of pharmacovigilance quality management systems and compliance principles
• Knowledge of regulatory authority inspection and audit processes preferably with experiencing supporting pharmacovigilance inspections and/or audits
• Experience developing, revising, or implementing SOPs, guidelines, work instructions, and related procedural documentation
• Experience working with outsourced PV vendors and/or business partners preferred
• Experience with process improvement initiatives preferred
• Expertise in clinical trial and post-marketed PV
• Understands key business drivers and uses this understanding to accomplish work
• Strong understanding of processes, procedures and systems used to accomplish the work and recognizes downstream impact on other functional areas
• Proficient with tools and processes that support work conducted by functional area
• Strong communications, problem-solving, analytical thinking skills.
• Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
• Strong project management skills
• Team player with ability to function in a multi-disciplinary environment
• Self-motivated, detail oriented, and able to prioritize and plan effectively
• Strong technical skills / software skills (i.e., MS Excel) and drug safety databases(e.g., Argus)

Nice To Haves

• Experience in supporting regulatory authority inspections of GVP and process improvement initiatives.
• Healthcare professional and vendor management experience preferred
• Master's, PA or PharmD in scientific field AND 2+ years of similar experience noted above

Responsibilities

• Supports DSPV quality and compliance activities for programs in clinical development and post-approval
• Coordinates and supports the management of PV deviations (internally and with vendors), including documentation, investigation, root cause analysis, corrective and preventive actions (CAPAs), and effectiveness checks, as applicable
• Tracks quality and compliance issues through resolution and proactively follows up with responsible stakeholders to support timely completion of actions
• Supports the development, revision, periodic review, and implementation of DSPV standard operating procedures, guidelines, work instructions, and other controlled documents
• Supports PV training activities, including development and maintenance of training materials and monitoring of training completion, as applicable
• Supports ongoing PV inspection readiness activities, including maintenance of inspection-ready documentation, preparation of requested materials and tracking of resulting commitments and actions
• Collaborates cross-functionally (e.g. Clinical Operations, Quality, Regulatory Affairs) and other relevant stakeholders to support compliant PV processes as needed
• Interacts with PV vendors on defined compliance activities and supports monitoring of adherence to applicable PV procedures, agreements, and regulatory requirements
• Identifies opportunities for process improvement and participates in defined PV compliance improvement initiatives and workstreams.
• Other duties as assigned

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: Senior