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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 Biosciencesis 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 inSan Diego,Neurocrine Biosciencesspecializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. (*in collaboration with AbbVie)
About the Role:Provide scientific/clinical expertise, strategic input, and support for deliverables and activities associated with clinical and post-market pharmacovigilance. Support signal management activities, safety, and benefit-risk evaluations for assigned products and author aggerate reports (eg, PADER, DSUR, etc.). The Manager will be a key contributor to SOP development and revisions. May also work with the DSPV Ops group and assist with case processing activities as needed by the department._
Your Contributions (include, but are not limited to):Safety Scientist Lead for assigned programs or studies. Safety Scientist Lead provides clinical and operational safety support to the Clinical Development programs (eg, content review of protocols, study reports, Investigator Brochure, informed consents and other related documents, as applicable).
Conduct literature review for assigned programs
Lead the preparation of periodic safety reports (eg, PADER, DSURs) in accordance with regulatory requirements and standard operating procedure for assigned programs.
In collaboration with the DSPV Medical Director, performs aggregate safety data review and interpretation to support safety evaluations for assigned programs.
In collaboration perform signal detection and evaluation activities in accordance with SOPs and guidelines for assigned programs.
Manage and participate in Drug Safety Monitoring Boards or independent monitoring committee meetings, as applicable.
Contribute to SOP and guidelines development and revisions.
Participates in multidisciplinary teams at Neurocrine involving R & D project teams, clinical project managers, business management, regulatory, and others to execute clinical trials, assess new product opportunities, develop clinical research strategy and product development plans.
Support DSPV Operations with case processing activities as needed
Other duties as assigned
BS/BA or RN degree in related scientific field and 8+ years of experience in drug safety in the biotech/pharmaceutical industry with 3+ years of pharmacovigilance compliance experience. Experience in supporting regulatory authority inspections of GVP and process improvement initiatives. Experience with drug safety databases such as ARISg. Healthcare professional and vendor management experience preferred. OR
Master's degree in related scientific field and 6+ years of similar experience noted above. OR
PhD or PharmD in related scientific field and 3+ years of similar experience noted above
Some managerial / functional management or lead experience preferred.
Strong knowledge of US and EU pharmacovigilance regulatory requirements.
Strong knowledge of current pharmacovigilance practices.
Knowledge of drug safety databases; experience with ARISg is a plus.
Ability to evaluate, interpret and synthesize scientific data.
Proficiency with safety safety coding dictionaries (eg, MedDRA, WHODRUG)
Expertise in individual safety case report processing, including triage, data entry, quality review, and submission.
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.
Strong leadership and communication skills (both oral and written).
Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.