Director, Safety Scientist, Pharmacovigilance

Responsibilities

• Manage safety surveillance and signal detection activities for assigned products
• Represent PV at clinical study teams for assigned product
• Develop signal assessment reports under the oversight of the Program Safety Lead
• Collaborate with PV operations on medical review of ICSRs as needed
• Develop and contribute safety risk management plans across the product lifecycle
• Develop and manage periodic reports (DSUR/PBRER)
• Contribute to safety sections of regulatory submissions and responses
• Contribute to development of safety surveillance and risk management SOPs
• Participate in PV audits and inspections
• Represent Pharmacovigilance in internal and external committees

Requirements

• Health care professional degree (RN, BSN, PharmD) or advanced degree (Masters/PhD) in life sciences
• Minimum 10 years of pharmacovigilance experience in biopharmaceuticals
• At least 3 years of direct clinical or patient care experience
• Experience with MedDRA and drug coding reviews
• Expertise in global PV regulations, GVP and ICH guidelines
• Experience with individual case handling, signal management and aggregate reporting
• Exceptional communication and cross-functional collaboration skills

Preferred Qualifications

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

Benefits

• Annual bonus opportunity, medical, dental, vision, life and disability insurance
• 401(K) plan with match, stock options, flexible paid time off, parental leave

About the Company

• MapLight Therapeutics is a clinical stage biotech focused on drug discovery for central nervous system disorders.