Associate Director, DSPV, Europe

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 suffering for people with great needs.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, 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 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 and Facebook. (*in collaboration with AbbVie)

About the Role:

The Associate Director DSPV Europe will report to the Executive Medical Director Europe and assume responsibility for leading global pharmacovigilance functions across all Neurocrinegroup companies including managing relationships withNeurocrine’s global licensing and distribution partners in conjunction with the Europe Qualified Person for Pharmacovigilance (QPPV) and the Business Development function.

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Your Contributions:

• Be a member of the pharmacovigilance team reporting to the Executive Medical Director Europe.

• Provide operational leadership for the Neurocrinepharmacovigilance system and oversight   of the pharmacovigilance vendors to ensure compliance with Good Pharmacovigilance Practice (GVP), The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and local requirements for territories where Neurocrine’s products are marketed.

• Oversee pharmacovigilance service providers and ensure timely safety case processing and reporting.

• Develop and monitor quality KPIs for all pharmacovigilance activities as well as compliance metrics

• Provide ongoing support to the QPPV to ensure they have the information required to fulfil pharmacovigilance regulatory obligations including GVP.

• Ensure the Pharmacovigilance System Master Files for EEA and GB are up to date and inspection ready.

• Lead and facilitate the preparation of aggregate reports such as Periodic Safety Update Reports, Development Safety Update Reports and similar documents with support from the wider pharmacovigilance team.

• Liaise with partners to understand local regulatory requirements of such documents.

• Work closely with the relevant stakeholders including VP, General Manager Europe and  to define pharmacovigilance arrangements with Alliance’s  partners and assume responsibility for integration of partner pharmacovigilance into the Neurocrineglobal pharmacovigilance system.

• Support Alliance’s  and work with relevant stakeholders to maintain relationships with existing partners and develop relationships with new partners.

• With input from QPPV, relevant stakeholders including global DSPV team, develop and update as required Safety Data Exchange Agreements/Pharmacovigilance agreements with relevant partners.

• Be the main point of contact for pharmacovigilance forNeurocrine’s partners.

• Work closely with the Quality function to ensure the Neurocrineand Vendor Quality Management Systems support EU/GB GVP and other international pharmacovigilance requirements.

• Develop and execute along with the Senior Director Quality Europe a program of in-house auditing of pharmacovigilance systems in Neurocrineand its partners

• Represent and support Neurocrinein pharmacovigilance inspections and audits.

• Lead the development and revision of SOPs relevant to pharmacovigilance activities.

• Adhere to Neurocrine’s quality assurance system and comply with the relevant SOPs.

• Manage deviations and corrective and preventative actions (CAPA).

• Responsibilities apply across all GXPs for all NeurocrineGroup companies including NeurocrineEurope B.V.

• Perform all business-related activities that may be reasonably requested and as instructed by the respective Company Director Europe  Executive Team member

• Complete all the above activities within the framework and in compliance with Neurocrine SOPs and other documentation in force within the Group.

Requirements:

• BS/BA degree and 10+ years clinical safety and pharmacovigilance experience OR

• Master’s degree preferred and 8+ years clinical safety and pharmacovigilance experience

• Degree in life sciences, nursing, or pharmacy

• 10 years clinical safety and pharmacovigilance experience

• Strong technical pharmacovigilance knowledge including protocol design, aggregate reports, signal detection and risk evaluation

• Experience with the use of safety databases

• Strong knowledge of MedDRA coding

• A willingness to be hands on when needed, but the ability to provide higher level guidance

• Strong interpersonal skills to build internal and external relationships

• Right to live and work in UK

• Experience working in variety of different pharmacovigilance roles including CROs and small biotechnology companies

• Rare disease experience

• Previous experience in similar role with vendor oversight

• Understanding of global pharmacovigilance regulations outside of the EEA/GB

• Experience in pharmacovigilance benefit risk in addition to operational roles

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.