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Manager, Safety Operations - Boston, United States - Cerevel Therapeutics
Description
Company OverviewCerevel 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.
The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions.
Role Summary
We are looking for an experienced Drug Safety/pharmacovigilance professional who will be an integral member of the Safety Operations and Compliance group within the Global Drug Safety (GDS) department.
This individual will be responsible for supporting the GDS Director in overseeing all aspects of safety vendor management including case workflow, regulatory submissions and compliance management across all Cerevel clinical study protocols.
Previous experience in end-to-end safety case management of collectable safety events (serious adverse events, adverse events of interest, pregnancy) from clinical studies.
Additional experience sought includes end user experience/configuration of safety database; managing vendor to vendor communications; regulatory reporting proficiency and compliance (audit, metrics) experience.
Up-to-date knowledge of current global regulations and industry guidelines governing pharmacovigilance is critical.This role reports to the GDS Director of Safety Operations and Compliance but requires the ability to work independently and collaboratively with associated departments within the Clinical Medical Organization.
Key ResponsibilitiesParticipates in the daily management, operational oversight, and execution of delegated operational safety tasks for all Cerevel clinical programs
Represents GDS Operations and Compliance ("GDS Operations Lead") within clinical development teams, as required
Provide Sponsor oversight of delegated safety responsibilities outsourced to safety vendor, including the timely and accurate execution of the processes defined within the applicable Safety Management and Safety Reporting plans
In conjunction with others in GDS Operations team, oversee case workflow (case receipt through submission) between safety vendor and Cerevel Safety Medical Reviewer
Additional tasks include:
Oversees/ensures safety case queries are resolved as per defined processes (interfacing with clinical operations team and clinical vendors, as required)
Monitors performance (metrics, other reports) of the safety vendor and the quality output of the ICSRs; provides appropriate feedback and training
As required, present safety reporting processes according to study protocol at Investigator Meetings or to other required audience
Ensures safety cases are closed within required timelines with resolution of required queries
Supports safety data reconciliation activities and ensures safety vendor responsibilities are completed within the required timelines
Monitoring of reporting and quality compliance through case oversight and quality metrics report review; ensures the implementation of effective corrective and preventative action plans are in place for any quality issues
Collaborates with Quality department to effect vendor inspections and internal department audits in effort to maintain a state of high PV inspection readiness for the organization
Competency in clear written and oral communication and excellent attention to detail and resolution of tasks and objectives
Required Qualifications
5+ years of clinical safety End to End case processing in small biotech/pharma and/or CRO
Pharmacovigilance project management experience
Desired Qualifications
Safety vendor management and oversight experience
Safety database configuration and end user experience
Education
BS or MS in Scientific Discipline
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 .
