Cerevel Therapeutics is a new biopharmaceutical company formed by Bain Capital and Pfizer that relentlessly finds paths through complexity to bring real progress and new treatment options to people living with neurological and neuropsychiatric disorders.
Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders including Parkinson’s, Alzheimer’s, epilepsy, schizophrenia and addiction.
Headquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people’s lives.
Cerevel aspires to develop and nurture a culture characterized by respect, trust, curiosity, compassion with a relentless focus on mission and results. Our patient- centricity guides our purpose, how we treat each other and what we work on every day. The successful candidate will bring his/her own unique thinking and approach to Cerevel while sharing our core values and convictions.
Reporting to the Sr. Director of Pharmacovigilance and Clinical Safety (PVCS), the Safety Scientist supports both early and late phase development activities providing essential safety oversight and input into all aspects of signal management across the entire development portfolio. This role will partner closely with other team members within PVCS (e.g., safety physicians, safety operations) and cross-functional stakeholders (e.g., clinical development, clinical operations, regulatory sciences), and contributes to safety deliverables required to manage and communicate the evolving safety profile of Cerevel therapies.
- Participate in development of safety-related data collection forms for clinical studies
- Review of the safety data from clinical studies
- Responsible for individual case safety reports (ICSRs) medical review
- Directs the planning, preparation, writing and review of aggregate reports (e.g. DSURs)
- Signal detection, evaluation, and management- Conduct data analysis to evaluate safety signals and author/present clinically meaningful results to key internal and external stakeholders
- Search and review adverse event data, literature, and other safety-relevant data to support signal detection and characterization of safety profile
- Assist in the development of risk management strategy and activities (e.g., Investigator’s Brochure Guidance to the Investigator, Risk Management Plan)
- Assist in responding to Health Authority requests and questions in a timely manner
- Support activities related to new drug applications, regulatory filings, and Agency meetings
- Support the PV review of study protocols, study reports, Investigator's Brochure (IB), informed consent form (ICF), statistical analysis plans (SAP) and other clinical study-related documents to ensure alignment with the safety strategy and risk communication for the product
- Minimum of 2 years of experience in pharmacovigilance (4+ years preferred)
- Experience in signal detection, evaluation, aggregate data analysis, and interpretation
- Experience with drug safety case workflow software (ARGUS or ARISg)
- Self-starter and motivated individual
- Experience with document writing and versioning
- Excellent communication skills, both written and verbal
- Knowledge of Pharmaceutical dictionaries and understanding of MedDRA coding
- Understanding of relevant regulations for safety data collection and safety evaluation
- Experience using analytics tools (Spotfire, Tableau, etc.) preferred
- Experience in CNS drug development preferred
- PhD, RN, PharmD or MD degree required
Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.
© 2019 Cerevel Therapeutics, LLC.
CEREVEL and the CEREVEL logo are trademarks of Cerevel Therapeutics, LLC. All Rights Reserved.