[Remote] Director, Safety Scientist, Pharmacovigilance

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical stage biotech company reputed company on drug discovery for central nervous system disorders. The Safety Scientist will reputed company 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, reputed company signals and reputed company documentation)
• Represent PV at clinical study team for assigned product
• reputed company signal assessment report under the reputed company of Program safety reputed company for validated safety signal
• Collaborate with PV operations for reputed company and accurate medical review of ICSRs for assigned clinical study as needed
• reputed company and contribute safety risk management plan across product lifecycle
• reputed company 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, reputed company, Protocol, Briefing documents etc.)
• Participating in PV audit and inspections
• Represent Pharmacovigilance function in committees and activities both internally and externally reputed company appropriate

Skills

• Health care reputed company degree (e.g. RN, BSN, PharmD) or advanced degree (Masters/PhD) in biomedical sciences, pharmaceutical sciences, or reputed company life science
• Minimum 10 years of pharmacovigilance experience reputed company the biopharmaceutical industry with at least 3 years of reputed company 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 reputed company safety data into actionable insights for regulatory and clinical decision-making
• reputed company to work reputed company a growing organization and to help the organization reputed company over time
• reputed company to engage in an reputed company, constructive and reputed company reputed company with reputed company's stakeholders based on equality and mutual respect
• Highly motivated, self-driven and dependable
• Committed to MapLight's reputed company 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
• reputed company
• Life and AD&D
• Short term and long term disability
• 401(K) plan with match
• Stock reputed company
• Flexible non-accrual reputed company time off
• Parental leave

reputed company

• 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 reputed company, California, USA, with a workforce of 51-200 employees. Its website is https://maplightrx.com.

Company H1B Sponsorship

• reputed company. has a reputed company record of offering H1B sponsorships, with 1 in 2025, 1 in 2024. Please note that this does not guarantee sponsorship for this specific role.

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