Neurocrine Biosciences
Principal Safety Scientist
Neurocrine Biosciences, San Diego, California, United States, 92154
Overview
Before applying for this role, please read the following information about this opportunity found below. Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to relieving suffering for people with great needs. The company focuses on discovering and developing treatments for under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (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 and author periodic safety reports (e.g., PADER, DSUR) for assigned programs. Contribute to SOP development and revisions. May work with the DSPV Operations 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, providing clinical and operational safety support to Clinical Development programs (e.g., content review of protocols, study reports, Investigator Brochure, informed consents and other related documents).
Conduct literature review for assigned programs.
Lead the preparation of periodic safety reports (e.g., PADER, DSURs) in accordance with regulatory requirements and SOPs for assigned programs.
Collaborate with the DSPV Medical Director on aggregate safety data review and interpretation to support safety evaluations.
Collaborate with the DSPV Medical Director on signal detection and evaluation activities according to SOPs and guidelines.
Participate in independent Data Monitoring Committee meetings, as applicable.
Contribute to SOP and guidelines development and revisions.
Participate in multidisciplinary Neurocrine teams involving R&D, Clinical Operations, Regulatory, and others to execute clinical trials.
Support DSPV Operations with case processing activities as needed.
Other duties as assigned.
Requirements
BS/BA or RN in a related scientific field with 8+ years of experience in drug safety in biotech/pharmaceutical industry, and 3+ years of pharmacovigilance compliance experience. Experience with regulatory inspections (GVP) and process improvement. Experience with drug safety databases such as ARISg. Healthcare professional and vendor management experience preferred OR
Master's degree in related scientific field with 6+ years of similar experience OR
PhD or PharmD in related scientific field with 4+ years of similar experience
Strong knowledge of US and EU pharmacovigilance regulatory requirements
Strong knowledge of current pharmacovigilance practices
Knowledge of drug safety databases; ARISg experience is a plus
Ability to evaluate, interpret and synthesize scientific data
Proficiency with safety coding dictionaries (e.g., MedDRA, WHODRUG)
Expertise in individual safety case report processing from triage to submission
Ability to work cross-functionally and improve efficiency on cross-functional issues
Strong problem-solving and communication skills (oral and written)
Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment. We encourage you to apply even if your experience or qualifications don’t line up exactly with the job description.
Compensation and Benefits The annual base salary is expected to be in the range of $128,200.00 – $185,900.00, with individual pay decisions based on location, role scope, duties, experience, and skills. This position offers an annual bonus target of 30% of base salary and eligibility to participate in the equity-based long-term incentive program. Benefits include retirement savings with company match, paid vacation, holidays and personal days, caregiver/parental and medical leave, and health benefits (medical, prescription, dental, vision).
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Science
#J-18808-Ljbffr
Before applying for this role, please read the following information about this opportunity found below. Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to relieving suffering for people with great needs. The company focuses on discovering and developing treatments for under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (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 and author periodic safety reports (e.g., PADER, DSUR) for assigned programs. Contribute to SOP development and revisions. May work with the DSPV Operations 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, providing clinical and operational safety support to Clinical Development programs (e.g., content review of protocols, study reports, Investigator Brochure, informed consents and other related documents).
Conduct literature review for assigned programs.
Lead the preparation of periodic safety reports (e.g., PADER, DSURs) in accordance with regulatory requirements and SOPs for assigned programs.
Collaborate with the DSPV Medical Director on aggregate safety data review and interpretation to support safety evaluations.
Collaborate with the DSPV Medical Director on signal detection and evaluation activities according to SOPs and guidelines.
Participate in independent Data Monitoring Committee meetings, as applicable.
Contribute to SOP and guidelines development and revisions.
Participate in multidisciplinary Neurocrine teams involving R&D, Clinical Operations, Regulatory, and others to execute clinical trials.
Support DSPV Operations with case processing activities as needed.
Other duties as assigned.
Requirements
BS/BA or RN in a related scientific field with 8+ years of experience in drug safety in biotech/pharmaceutical industry, and 3+ years of pharmacovigilance compliance experience. Experience with regulatory inspections (GVP) and process improvement. Experience with drug safety databases such as ARISg. Healthcare professional and vendor management experience preferred OR
Master's degree in related scientific field with 6+ years of similar experience OR
PhD or PharmD in related scientific field with 4+ years of similar experience
Strong knowledge of US and EU pharmacovigilance regulatory requirements
Strong knowledge of current pharmacovigilance practices
Knowledge of drug safety databases; ARISg experience is a plus
Ability to evaluate, interpret and synthesize scientific data
Proficiency with safety coding dictionaries (e.g., MedDRA, WHODRUG)
Expertise in individual safety case report processing from triage to submission
Ability to work cross-functionally and improve efficiency on cross-functional issues
Strong problem-solving and communication skills (oral and written)
Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment. We encourage you to apply even if your experience or qualifications don’t line up exactly with the job description.
Compensation and Benefits The annual base salary is expected to be in the range of $128,200.00 – $185,900.00, with individual pay decisions based on location, role scope, duties, experience, and skills. This position offers an annual bonus target of 30% of base salary and eligibility to participate in the equity-based long-term incentive program. Benefits include retirement savings with company match, paid vacation, holidays and personal days, caregiver/parental and medical leave, and health benefits (medical, prescription, dental, vision).
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Science
#J-18808-Ljbffr