C

Safety Scientist

Cerevel Therapeutics

Date listed

1 month ago

Employment Type

Full time

Remote

Yes

Found on:

Responsive image Remote OK

Keywords: remote

Company Overview

Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders, including schizophrenia, epilepsy, Parkinson’s disease and substance use disorder.     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 trust, respect, courage, curiosity, and 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 their own unique thinking and approach to Cerevel while sharing our core values and convictions.

Role Summary

Reporting to the Director of Global Drug Safety, the Safety Scientist supports early and late-phase program development activities, providing essential safety oversight and input into all aspects of safety signal management across the entire development portfolio. This role will partner closely with program safety leads and other clinical development colleagues and contribute to safety deliverables required to manage and communicate the evolving safety profile.

Key Responsibilities * Helps the program safety lead with the planning, preparation, writing, and review of aggregate reports (e.g., DSURs) * Actively involved with Signal detection activities, including validation, prioritization, evaluation, and management * Searches and reviews adverse event data, literature, and other safety-relevant data for signal detection activities * Assists in the development of risk management strategies and activities * Assists in responding to health authority requests and questions * Supports activities related to new drug applications and other regulatory filings * Supports the review of clinical protocols, study reports, Investigator’s Brochure (IB), informed consent form (ICF), Statistical Analysis Plans, and other clinical study-related documents to ensure alignment with the safety strategy and risk communication * May be occasionally involved in reviewing individual case safety reports (ICSRs) and analysis of similar events (AESIs) medical review

Required Qualifications * Minimum of 2 years’ experience in pharmacovigilance (including PV fellowship) * Experience in signal detection, evaluation, aggregate data analysis, and interpretation * Experience with document writing and version * Excellent communication skills, both written and verbal * Knowledge of Pharmaceutical dictionaries and understanding of MedDRA coding

Desired Qualifications * Experience using analytics tools (Spotfire, Tableau, Elluminate, etc.) preferred * Experience in CNS drug development is preferred

Education * Ph.D., 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. 

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