Director, Safety Scientist, Pharmacovigilance

Who We Are: 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.

What You’ll Do:

The Safety Scientist will be responsible for high quality safety surveillance activities including medical review of individual case safety reports (ICSRs), aggregate report production, safety governance meeting coordination, safety signal detection and assessment, and safety risk management activities for assigned products. This individual will collaborate with Program Safety Lead and other program team members, pharmacovigilance operations, and CROs to ensure proactive safety surveillance in compliance with global regulations.

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.

We consider these behaviors we seek in all MapLight employees.

• You can participate and work effectively with multiple cross-functional teams.

• You have strong interpersonal skills and understanding relationships are key to being successful.

• You are a leader. Teams love working with you, and you are someone who takes pride in mentoring and supporting the careers of others.

• You’re a team player who is willing to roll up your sleeves and get the job done.