Neurocrine Biosciences
Overview
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Sr. Specialist, Safety
role at
Neurocrine Biosciences .
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 Support pharmacovigilance (PV) Operations activities including vendor oversight, case processing and submission. Develop PV guidelines and ensure the uniform and timely processing of adverse events for NBI compounds in clinical development and post-approval. Ensure compliance with standard operating procedures and global regulations. The Sr. Specialist, Safety will work independently, with limited supervision. This position will require onsite participation at a minimum of 3 days a week, with the possibility of more based on business needs.
Your Contributions (include, But Are Not Limited To)
Provide oversight of outsourced safety-related functions
Coordinate and perform adverse event data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities to comply with protocol and regulatory specific requirements
Prepare for expedited reporting of SAEs, including preparation of analysis of similar events
Support the preparation of periodic safety reports in accordance with regulatory requirements and standard operating procedure
Support signal detection and evaluation activities in accordance with SOPs and guidelines
Participate in developing DSPV Operations SOPs and guidelines and provide staff training
Act as liaison to vendor for case processing activities and ensure adherence to processes and regulatory requirements
Develop study-specific case processing reference information for staff and provide training
Support safety database activities as needed
Other duties as assigned
Requirements
BS/BA in a scientific field or RN degree and 4+ years of pharmacovigilance or clinical and/or medical research or equivalent experience. Experience in and knowledge of drug safety databases (e.g., ARISg, Argus), signal evaluation and risk management, aggregate data analysis, interpretation and synthesis, and authoring periodic aggregate safety reports (e.g. PBRERs, DSURs) and RMPs. OR
Master’s degree in scientific field and 2+ years of pharmacovigilance or clinical and/or medical research or equivalent experience. Experience in and knowledge of drug safety databases (e.g., ARISg, Argus), signal evaluation and risk management, aggregate data analysis, interpretation and synthesis, and authoring periodic aggregate safety reports (e.g. PBRERs, DSURs) and RMPs. OR
PharmD or PA without experience
Strong vendor management skills
Ability to evaluate, interpret and synthesize scientific data
Strong knowledge of ICH guidelines, US and EU pharmacovigilance regulatory requirements
Knowledge of drug safety systems (e.g. ARISg and Argus)
Strong knowledge of current PV practices
Vendor management experience preferred
Expertise in clinical trial and post-marketed PV
Understands key business drivers and uses this understanding to accomplish work
Has 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
Ability to work as part of a team; may train lower levels
Excellent computer skills
Strong communications, problem-solving, analytical thinking skills
Detail oriented yet can see broader picture for department
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)
Neurocrine Biosciences is an EEO/Disability/Vets employer.
We are committed to building a workplace of belonging, respect, and empowerment, 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.
Compensation and Benefits The annual base salary we reasonably expect to pay is $108,600.00-$157,350.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
Job Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Information Technology
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Sr. Specialist, Safety
role at
Neurocrine Biosciences .
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 Support pharmacovigilance (PV) Operations activities including vendor oversight, case processing and submission. Develop PV guidelines and ensure the uniform and timely processing of adverse events for NBI compounds in clinical development and post-approval. Ensure compliance with standard operating procedures and global regulations. The Sr. Specialist, Safety will work independently, with limited supervision. This position will require onsite participation at a minimum of 3 days a week, with the possibility of more based on business needs.
Your Contributions (include, But Are Not Limited To)
Provide oversight of outsourced safety-related functions
Coordinate and perform adverse event data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities to comply with protocol and regulatory specific requirements
Prepare for expedited reporting of SAEs, including preparation of analysis of similar events
Support the preparation of periodic safety reports in accordance with regulatory requirements and standard operating procedure
Support signal detection and evaluation activities in accordance with SOPs and guidelines
Participate in developing DSPV Operations SOPs and guidelines and provide staff training
Act as liaison to vendor for case processing activities and ensure adherence to processes and regulatory requirements
Develop study-specific case processing reference information for staff and provide training
Support safety database activities as needed
Other duties as assigned
Requirements
BS/BA in a scientific field or RN degree and 4+ years of pharmacovigilance or clinical and/or medical research or equivalent experience. Experience in and knowledge of drug safety databases (e.g., ARISg, Argus), signal evaluation and risk management, aggregate data analysis, interpretation and synthesis, and authoring periodic aggregate safety reports (e.g. PBRERs, DSURs) and RMPs. OR
Master’s degree in scientific field and 2+ years of pharmacovigilance or clinical and/or medical research or equivalent experience. Experience in and knowledge of drug safety databases (e.g., ARISg, Argus), signal evaluation and risk management, aggregate data analysis, interpretation and synthesis, and authoring periodic aggregate safety reports (e.g. PBRERs, DSURs) and RMPs. OR
PharmD or PA without experience
Strong vendor management skills
Ability to evaluate, interpret and synthesize scientific data
Strong knowledge of ICH guidelines, US and EU pharmacovigilance regulatory requirements
Knowledge of drug safety systems (e.g. ARISg and Argus)
Strong knowledge of current PV practices
Vendor management experience preferred
Expertise in clinical trial and post-marketed PV
Understands key business drivers and uses this understanding to accomplish work
Has 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
Ability to work as part of a team; may train lower levels
Excellent computer skills
Strong communications, problem-solving, analytical thinking skills
Detail oriented yet can see broader picture for department
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)
Neurocrine Biosciences is an EEO/Disability/Vets employer.
We are committed to building a workplace of belonging, respect, and empowerment, 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.
Compensation and Benefits The annual base salary we reasonably expect to pay is $108,600.00-$157,350.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
Job Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Information Technology
#J-18808-Ljbffr