Director, Safety Scientist, Pharmacovigilance

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.

Requirements

• 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
• Highly 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.
• Salary Range
• $220,000 - $240,000 USD
• EEOC Statem

Benefits

Additional Information

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.

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