Director, Safety Scientist, Pharmacovigilance

MapLight Therapeutics•Burlington, MA

1d•Hybrid

About The Position

MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.

Requirements

Health care professional degree (e.g. RN, BSN, PharmD) or advanced degree (Masters/PhD) in biomedical sciences, pharmaceutical sciences, or related life science.
Minimum 10 years of pharmacovigilance experience within the biopharmaceutical industry with at least 3 years of direct clinical/patient care experience
Competence in conducting safety data reviews, preparation of aggregate reports, signal detection and risk management plans for investigational and/or post-marketed products
Experience with MedDRA and drug coding reviews
Demonstrated expertise in global PV regulations, GVP and ICH guidelines, safety systems, and drug development processes
Experience in PV processes for individual case handling, signal management, aggregate data review, aggregate reports, and audits/inspections
Exceptional communication and cross-functional collaboration skills
Strategic thinker with the ability to translate complex safety data into actionable insights for regulatory and clinical decision-making
Able to work within a growing organization and to help the organization evolve over time
Able to engage in an open, constructive and continuous dialogue with the Company’s stakeholders based on equality and mutual respect
Highly motivated, self-driven and dependable
Committed to MapLight's Core Beliefs and Values

Nice To Haves

Post-graduate training in epidemiology (e.g. MPH)
Safety surveillance and risk management experience in neuroscience, psychiatry or neurodegenerative disease area

Responsibilities

Manage safety surveillance and signal detection activities (period review of aggregate safety data, safety surveillance team meetings, track signals and related documentation)
Represent PV at clinical study team for assigned product
Develop signal assessment report under the oversight of Program safety lead for validated safety signal
Collaborate with PV operations for timely and accurate medical review of ICSRs for assigned clinical study as needed
Develop and contribute safety risk management plan across product lifecycle
Develop and manage periodic reports (DSUR/PBRER)
Contribute for data analysis and authoring of safety sections for regulatory submissions and regulatory responses
Contribute for the development or updates of safety surveillance and risk management SOPs, templates etc.
Collaborate with clinical study teams on safety surveillance deliverables (IB, RSI, Protocol, Briefing documents etc.)
Participating in PV audit and inspections
Represent Pharmacovigilance function in committees and activities both internally and externally when appropriate.