Principal Drug Safety Scientist
2 weeks ago
We are seeking a highly skilled Principal Drug Safety Scientist to join our team at Neurocrine Biosciences. As a key member of our pharmacovigilance team, you will be responsible for providing scientific and clinical expertise to support the development and implementation of safety strategies for our products.
Key Responsibilities- Provide scientific and clinical expertise to support the development and implementation of safety strategies for our products.
- Support signal management activities, safety and benefit-risk evaluations, and author periodic safety reports (e.g., PADER, DSUR) for assigned programs.
- Conduct literature reviews for assigned programs and lead the preparation of periodic safety reports in accordance with regulatory requirements and standard operating procedures.
- Collaborate with the DSPV Medical Director to perform aggregate safety data review and interpretation to support safety evaluations for assigned programs.
- Participate in independent Data Monitoring Committee meetings, as applicable, and contribute to SOP and guidelines development and revisions.
- Support DSPV Operations with case processing activities as needed.
- BS/BA or RN degree in a related scientific field and 8+ years of experience in drug safety in the biotech/pharmaceutical industry with 3+ years of pharmacovigilance compliance experience.
- Experience in supporting regulatory authority inspections of GVP and process improvement initiatives.
- Experience with drug safety databases such as ARISg.
- Strong knowledge of US and EU pharmacovigilance regulatory requirements.
- Strong knowledge of current pharmacovigilance practices.
- Ability to evaluate, interpret, and synthesize scientific data.
- Proficiency with safety coding dictionaries (e.g., MedDRA, WHODRUG).
- Expertise in individual safety case report processing, including triage, data entry, quality review, and submission.
We offer a competitive annual base salary of $125,700.00-$182,000.00, an annual bonus with a target of 30% of the earned base salary, and eligibility to participate in our equity-based long-term incentive program. Additionally, we offer a comprehensive benefits package, including 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.
We are an EEO/AA/Disability/Vets employer and are committed to building a diverse, equitable, and inclusive workplace. We recognize that there are a variety of ways to meet our requirements 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.
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Principal Drug Safety Scientist
2 weeks ago
San Diego, California, United States Neurocrine Biosciences Full timeAbout the RoleWe are seeking a highly skilled Principal Drug Safety Scientist to join our team at Neurocrine Biosciences. As a key member of our pharmacovigilance team, you will be responsible for providing scientific and clinical expertise to support the development and implementation of safety strategies for our products.Key ResponsibilitiesProvide...
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Principal Drug Safety Scientist
1 week ago
San Diego, California, United States Neurocrine Bioscience Full timeAbout the RoleWe are seeking a highly skilled Principal Drug Safety Scientist to join our team at Neurocrine Biosciences. As a key member of our pharmacovigilance department, you will be responsible for providing scientific and clinical expertise to support the development and implementation of safety strategies for our products.Key ResponsibilitiesProvide...
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San Diego, California, United States Neurocrine Bioscience Full timeAbout the RoleWe are seeking a highly skilled Principal Drug Safety Scientist to join our team at Neurocrine Biosciences. As a key member of our pharmacovigilance team, you will be responsible for providing scientific and clinical expertise to support the development and implementation of safety strategies for our products.Key ResponsibilitiesProvide...
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