Sr. Specialist, DSPV Operations

Who We Are:

About the Role:

Your Contributions (include, but are not limited to):

Requirements:

• BS/BA in a scientific field or RN degree AND 4+ years in drug safety in the biotech/pharmaceutical industry with 2+ years of pharmacovigilance compliance experience. Preferred experience: Experience in supporting regulatory authority inspections of GVP and process improvement initiatives.. Healthcare professional and vendor management experience preferred OR
• Master's, PA or PharmD in scientific field AND 2+ years of similar experience noted above
• Strong knowledge of ICH guidelines, US and EU pharmacovigilance regulatory requirements
• Knowledge of pharmacovigilance quality management systems and compliance principles
• Knowledge of regulatory authority inspection and audit processes preferably with experiencing supporting pharmacovigilance inspections and/or audits
• Experience developing, revising, or implementing SOPs, guidelines, work instructions, and related procedural documentation
• Experience working with outsourced PV vendors and/or business partners preferred
• Experience with process improvement initiatives preferred
• Expertise in clinical trial and post-marketed PV
• Understands key business drivers and uses this understanding to accomplish work
• 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
• Strong communications, problem-solving, analytical thinking skills.
• 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) and drug safety databases(e.g., Argus)
• #LI_RS1
• 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.
• The annual base salary we reasonably expect to pay is $103,300.00-$141,000.00. 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.
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Preferred Qualifications

• BS/BA in a scientific field or RN degree AND 4+ years in drug safety in the biotech/pharmaceutical industry with 2+ years of pharmacovigilance compliance experience. Preferred experience: Experience in supporting regulatory authority inspections of GVP and process improvement initiatives.. Healthcare professional and vendor management experience preferred OR
• Experience working with outsourced PV vendors and/or business partners preferred
• Experience with process improvement initiatives preferred
• The annual base salary we reasonably expect to pay is $103,300.00-$141,000.00. 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.