[Remote] Director, Safety Scientist, Pharmacovigilance
Note: The job is a remote job and is open to candidates in USA. MapLight Therapeutics is a clinical stage biotech company focused on drug discovery for central nervous system disorders. The Safety Scientist will oversee safety surveillance activities, collaborate with various teams, and ensure compliance with global regulations for pharmacovigilance activities.
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
Skills
- 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
- Post-graduate training in epidemiology (e.g. MPH)
- Safety surveillance and risk management experience in neuroscience, psychiatry or neurodegenerative disease area
Benefits
- 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
- Parental leave
Company Overview
- Maplight is a biopharmaceutical company discovering and developing novel therapeutics for patients with disorders of the central nervous system (CNS). It was founded in 2018, and is headquartered in Palo Alto, California, USA, with a workforce of 51-200 employees. Its website is https://maplightrx.com.
Company H1B Sponsorship
- MapLight Therapeutics, Inc. has a track record of offering H1B sponsorships, with 1 in 2025, 1 in 2024. Please note that this does not guarantee sponsorship for this specific role.