Director, Safety Scientist, Pharmacovigilance

Who We Are

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

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.

Qualifications

• Health care professional degree (e.g. RN, BSN, PharmD) or advanced degree (Masters/PhD) in biomedical sciences, pharmaceutical sciences, or related life science.
• Preferred: Post-graduate training in epidemiology (e.g. MPH)
• Minimum 10 years of pharmacovigilance experience within the biopharmaceutical industry with at least 3 years of direct clinical/patient care experience
• Preferred: Safety surveillance and risk management experience in neuroscience, psychiatry or neurodegenerative disease area
• 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
• Hightly motivated, self-driven and dependable
• Committed to MapLight's Core Beliefs and Values

Location

This is a remote US position. Hybrid 3 day in office policy for anyone located within 50 miles of Redwood City, CA or Burlington, MA.

Travel

Ability to travel as needed (up to 10%) for corporate and departmental meetings.

EEOC Statement

MapLight Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

Compensation

Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. Additional compensation/benefits include annual bonus opportunity, medical, dental, vision, life and AD&D, short term and long term disability, 401(K) plan with match, stock options, flexible non-accrual paid time off, and parental leave.

Salary Range

$220,000 - $240,000 USD

EEOC Statement

MapLight Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.