Neurocrine Biosciences
Global Head, Medical Drug Safety & Pharmacovigilance
US CA San Diego · Senior
Sponsorship not specified$322k-$439kDetected 9 days ago
Product ManagementFDA RegulatoryPharmacovigilanceLeadershipCommunicationCollaborationProblem SolvingMentoringRegulatory Affairs
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odds of building a lasting career here
61Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
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Files H-1B transfers
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About the role
- This leader will advise senior and executive stakeholders on complex safety, development, regulatory, and portfolio decisions
- represent Drug Safety in senior governance forums
- and help shape the future direction, capabilities, and impact of the Drug Safety organization. _
Responsibilities
- At Neurocrine, strong leadership drives both business results and team success.
- We look for leaders who think strategically, anticipate what's ahead and set clear direction, while building and empowering high-performing teams.
- Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability.
- Build trusted partnerships with senior and executive leaders across Clinical Development, Regulatory Affairs, Clinical Operations, R&D, and other functions.
- Support safety strategy and assessments for Board and other senior governance discussions.
- Support evaluation of individual and aggregate safety information to identify, investigate, and interpret potential safety signals.
Requirements
- You can move seamlessly between detailed safety science and enterprise strategy
- Knowledge and Qualifications
- Strong knowledge of international regulatory requirements, particularly FDA and EU/EEA regulations, and pre- and post-marketing drug safety standards.
- Ability to manage multiple complex programs and priorities with a high degree of accountability, accuracy, and effectiveness.
- 6-10+ years of experience in pharmacovigilance in a pharmaceutical or biotechnology company.
Nice to have
- experience with ARISg is preferred.
- Proficiency with safety databases and safety coding dictionaries such as MedDRA and WHODRUG
- M.D degree plus accredited residency in relevant clinical specialty (eg Internal Medicine, Family Practice, Neurology) and Board certification and clinical/industry experience.
Compensation
- Support or contribute to safety-related regulatory submissions and periodic reports, including DSURs, IND Annual Reports, PADERs, PBRERs, PSURs, and responses to regulatory inquiries.
Benefits
- Partner with the Vice President, Drug Safety to establish and advance medical safety strategy and priorities across Neurocrine's investigational and marketed portfolio.
Company info
- Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. ( *in collaboration with AbbVie )
- At Neurocrine, strong leadership drives both business results and team success. We look for leaders who think strategically, anticipate what's ahead and set clear direction, while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability.
- Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs.
- We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders.
- The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas.
- For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions.
- We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science.
- For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. ( *in collaboration with AbbVie )
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