Director, Safety Scientist, Pharmacovigilance

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee safety surveillance and signal detection initiatives, including routine assessments of aggregate safety data, safety surveillance team meetings, and documentation of signals.

• Act as the representative for Pharmacovigilance in clinical study teams for designated products.

• Create signal assessment reports under the guidance of the Program Safety Lead.

• Partner with PV Operations for the timely and precise medical review of Individual Case Safety Reports (ICSRs) pertaining to assigned clinical studies.

• Formulate and contribute to safety risk management strategies throughout the product lifecycle.

• Develop and manage regular reports, such as Development Safety Update Reports (DSUR) and Periodic Benefit-Risk Evaluation Reports (PBRER).

• Provide data analysis and author safety sections for regulatory submissions and responses.

• Assist in the creation of safety surveillance and risk management Standard Operating Procedures (SOPs) and templates.

• Work together with clinical study teams on safety surveillance deliverables, including Investigator’s Brochure (IB), Risk Summary Information (RSI), Protocol, and briefing documents.

• Engage in Pharmacovigilance audits and inspections.

• Serve as a representative of Pharmacovigilance in both internal and external committees and activities.

• Collaborate with the Program Safety Lead, program team members, PV Operations, and Contract Research Organizations (CROs) to ensure proactive safety surveillance that adheres to global regulations.

• MapLight Therapeutics is a clinical-stage biotech firm dedicated to drug discovery for central nervous system disorders, utilizing optogenetics, in vivo physiology, and spatial transcriptomics.

⛳️ Requirements

• A healthcare professional degree (e.g., RN, BSN, PharmD) or an advanced degree (Masters/PhD) in biomedical sciences, pharmaceutical sciences, or related life sciences.

• At least 10 years of experience in pharmacovigilance within the biopharmaceutical sector.

• Minimum of 3 years of direct clinical/patient care experience.

• Proficient in safety data evaluations, aggregate report preparation, signal detection, and risk management plans for investigational and/or post-marketed products.

• Familiarity with MedDRA and drug coding evaluations.

• In-depth knowledge of global pharmacovigilance regulations, Good Pharmacovigilance Practices (GVP), ICH guidelines, safety systems, and drug development processes.

• Experience in individual case management, signal management, aggregate data review, aggregate reporting, and audits/inspections.

• Willingness to travel as required, up to 10%.

• Preferred: Post-graduate training in epidemiology (e.g., MPH).

• Preferred: Experience in safety surveillance and risk management related to neuroscience, psychiatry, or neurodegenerative diseases.

• Outstanding communication skills and ability to collaborate across functions.

• Strategic thinker with the capability to interpret complex safety data into actionable insights.

• Ability to thrive in a growing organization and contribute to its evolution.

• Capacity to engage in open, constructive, and ongoing dialogue with stakeholders.

• Highly motivated, self-directed, and reliable.

• Commitment to MapLight's Core Beliefs and Values.

🏝️ Benefits

• Annual bonus opportunity.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Life insurance.

• Accidental Death & Dismemberment (AD&D) insurance.

• Short-term disability insurance.

• Long-term disability insurance.

• 401(K) plan with company match.

• Stock options.

• Flexible non-accrual paid time off.

• Parental leave.

• Up to 10% travel for corporate and departmental meetings.