Scientist, Safety
About The Position
The Scientist, Safety supports safety surveillance and risk management for assigned Neurocrine products throughout their lifecycles. The role contributes to aggregate report production, signal management, safety review meetings, and safety support for investigational products, including new drug applications and other regulatory filings. It also supports responses to health authorities and relationships with pharmacovigilance business partners. As needed, the role may assist the DSPV Operations group with case processing activities. The position works with multidisciplinary teams across research and development, clinical project management, business management, and regulatory functions to support clinical trials, product opportunities, research strategy, and product development plans. It also contributes to safety-related regulatory and clinical documents, literature review, safety data evaluation, inspections and audits, and maintenance of procedures and guidelines.
Requirements
- BS/BA degree in a related scientific field or RN degree and at least 2 years of pharmacovigilance, clinical research, medical research, or equivalent experience; alternatively, an MS/MA in a related scientific field or a PharmD or PA qualification with some relevant experience.
- Ability to recognize fundamental anomalies in data and identify issues in experiments or processes.
- Strong knowledge of one scientific discipline and good knowledge of scientific principles, methods, and techniques.
- Good knowledge of and demonstrated ability to work with laboratory equipment and tools.
- Knowledge of ICH guidelines and US and EU pharmacovigilance regulatory requirements.
- Working knowledge of drug safety systems such as ARISg and Argus.
- Knowledge of current pharmacovigilance practices, signal evaluation, and risk management.
- Working knowledge of aggregate data analysis, interpretation, and synthesis.
- Ability to review periodic aggregate safety reports, such as PBRERs and DSURs, and risk management plans.
- Ability to evaluate, interpret, and synthesize scientific data.
- Strong computer skills and good communication, problem-solving, and analytical thinking skills.
- Ability to work as part of a team and in a multidisciplinary environment.
- Detail-oriented, self-motivated, and able to prioritize and plan effectively.
- Ability to consider how decisions affect broader scientific goals.
Nice To Haves
- MS/MA degree in a related scientific field with some relevant industry experience.
- PharmD or PA qualification with some experience.
Responsibilities
- Participate in safety signal management to detect, analyze, and investigate safety signals.
- Execute risk management plans for assigned products during development and after approval.
- Perform assigned safety data reviews and interpret information to support safety evaluations.
- Support safety input for drug-safety regulatory reports and clinical study documents, including protocols, informed consent forms, investigator brochures, ISS documents, MedDRA coding of adverse events, product labeling, and the CCDS.
- Assist with safety-related regulatory submissions, including periodic and ad hoc aggregate reports such as DSURs, IND Annual Reports, PADERs, PBRERs, and PSURs, and respond to health authority requests.
- Participate in multidisciplinary teams to support clinical trials, assess product opportunities, and develop clinical research strategies and product development plans.
- Participate in testing processes and conventions for safety surveillance activities, including maintaining SOPs and guidelines.
- Collect responses to safety questions from internal and external stakeholders, including business partners.
- Review scientific literature for safety information.
- Support clinical trial pharmacovigilance activities by reviewing safety content in protocols, study reports, investigator brochures, informed consents, and related documents.
- Assist with document requests and responses during inspections and audits, and manage corrective and preventive actions.
- Perform other duties as assigned.
Benefits
- Annual bonus with a target of 20% of earned base salary.
- Eligibility to participate in an equity-based long-term incentive program.
- Retirement savings plan with company match.
- Paid vacation, holiday, and personal days.
- Paid caregiver, parental, and medical leave.
- Medical, prescription drug, dental, and vision coverage.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
