Who We Are:
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve patient suffering and enhance lives.
What We Do:
Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with 28 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, with three pivotal and five mid-stage clinical programs in multiple therapeutic areas. Headquartered in San Diego, Neurocrine Biosciences specializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. (*in collaboration with AbbVie)
About the Role:
(This position is based in San Diego at our Corp HQ- not a remote position)
The Manager, Drug Safety and Pharmacovigilance Operations is a key contributor to the success of the Drug Safety and Pharmacovigilance department. This position provides scientific/clinical expertise, strategic input, support for deliverables and activities associated with clinical and post-market pharmacovigilance. The Manager, DSPV Operations is an expert in global pre- and post-marketing safety and manages all DSPV Operations activities as well as support safety surveillance activities as needed.
Your Contributions (include, but are not limited to):
- Manage outsourced safety-related functions, including adverse event data entry, coding and assessment of adverse events, and regulatory submissions;
- Support DSPV compliance activities:
- Establishing compliance metrics and compliance monitoring;
- Manage deviations and CAPAs;
- Support inspection readiness activities; participate in audits;
- Develop SOP and guidelines and conduct training;
- Establish regulatory reporting requirements matrices per global requirements;
- Establish and maintain data entry guidelines and provide ongoing training to staff to ensure adherence to the guidelines;
- Assist in managing the safety database activities, including liaison to the safety database vendor, support for issue resolution, maintenance of safety database libraries, initiation of change control, system testing, as applicable, and training;
- Perform case review, adverse event coding review, tracking of reports, and regulatory reporting activities to comply with protocol and regulatory specific requirements;
- Prepare for expedited reporting of SAEs, including support the preparation of analysis of similar events;
- Support the preparation of periodic safety reports (eg, PADER, DSURs) in accordance with regulatory requirements and standard operating procedures;
- Support signal detection and evaluation activities in accordance with SOPs and guidelines;
- Provide safety content review of clinical protocols, study reports, Investigators Brochure, informed consents and other related documents, as applicable
- BS/BA in related scientific field or RN degree and 6+ years of experience in drug safety in the biotech/pharmaceutical industry with 3+ years of pharmacovigilance compliance experience, OR
- Master's degree in related scientific field and 4+ years of experience as noted above, OR
- PharmD, PhD, PA in related scientific field and 2+ years of experience as noted above;
- Experience in supporting regulatory authority inspections of GVP and process improvement initiatives preferred.
- Experience with drug safety databases such as ARISg preferred.
- Healthcare professional and vendor management experience preferred.
- Strong knowledge of US and EU pharmacovigilance regulatory requirements.
- Strong knowledge of current pharmacovigilance practices.
- Ability to evaluate, interpret and synthesize scientific data.
- Expert knowledge in global pre- and post-marketing safety, manages all DSPV compliance activities
- Strong knowledge of regulatory authority inspection process with a focus on pharmacovigilance.
- Understanding of audit/compliance program design
- Strong knowledge of drug safety databases. experience with ARISg is a plus
- Strong technical skills
- Requires understanding of how the team / work area relates to other related areas and uses that knowledge to improve efficiency and produce high-quality work on problems with cross-functional impact
- Identifies and resolves technical, operational and organizational problems/problems relating to own discipline
- Frequently works cross-functionally as the representative for their area
- Team player with ability to function in a multi-disciplinary environment.
- Self-motivated, detail oriented, and able to prioritize and plan effectively.
Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.