Director jobs in United States
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Director, Safety Scientist, Pharmacovigilance
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Director, Safety Scientist, Pharmacovigilance
MapLight Therapeutics, Inc.Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in pharmacovigilance, including safety data reviews, signal detection, and risk management plans. Proficient in developing safety assessment reports and collaborating with cross-functional teams to ensure compliance with global regulations.
Highest-signal resume keywords
Pharmacovigilance ExperienceSafety Data ReviewSignal DetectionGlobal PV RegulationsClinical Study Collaboration
About the role
Key responsibilities & impact- Manage safety surveillance and signal detection activities, including periodic review of aggregate safety data, safety surveillance team meetings, and signal documentation
- Represent Pharmacovigilance at clinical study teams for assigned products
- Develop signal assessment reports under the oversight of the Program Safety Lead
- Collaborate with PV Operations on timely and accurate medical review of ICSRs for assigned clinical studies
- Develop and contribute to safety risk management plans across the product lifecycle
- Develop and manage periodic reports, including DSUR and PBRER
- Contribute data analysis and author safety sections for regulatory submissions and responses
- Contribute to safety surveillance and risk management SOPs and templates
- Collaborate with clinical study teams on safety surveillance deliverables, including IB, RSI, Protocol, and briefing documents
- Participate in PV audits and inspections
- Represent Pharmacovigilance in internal and external committees and activities
- Collaborate with Program Safety Lead, program team members, PV Operations, and CROs to ensure proactive safety surveillance compliant with global regulations
- MapLight Therapeutics is a clinical-stage biotech company focused on drug discovery for central nervous system disorders, using optogenetics, in vivo physiology, and spatial transcriptomics
Requirements
What you’ll need- Health care professional degree (e.g. RN, BSN, PharmD) or advanced degree (Masters/PhD) in biomedical sciences, pharmaceutical sciences, or related life science
- Minimum 10 years of pharmacovigilance experience within the biopharmaceutical industry
- At least 3 years of direct clinical/patient care experience
- Competence in safety data reviews, aggregate report preparation, signal detection, and risk management plans for investigational and/or post-marketed products
- Experience with MedDRA and drug coding reviews
- Expertise in global PV regulations, GVP and ICH guidelines, safety systems, and drug development processes
- Experience in individual case handling, signal management, aggregate data review, aggregate reports, and audits/inspections
- Ability to travel as needed, up to 10%
- Preferred: Post-graduate training in epidemiology (e.g. MPH)
- Preferred: Safety surveillance and risk management experience in neuroscience, psychiatry or neurodegenerative disease
- Exceptional communication and cross-functional collaboration skills
- Strategic thinking and ability to translate complex safety data into actionable insights
- Ability to work within a growing organization and help it evolve
- Ability to engage in open, constructive and continuous dialogue with stakeholders
- Highly motivated, self-driven and dependable
- Commitment to MapLight's Core Beliefs and Values
Benefits
Comp & perks- Annual bonus opportunity
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- AD&D insurance
- Short-term disability
- Long-term disability
- 401(K) plan with match
- Stock options
- Flexible non-accrual paid time off
- Parental leave
- Up to 10% travel for corporate and departmental meetings
ATS Keywords
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Hard Skills
Aggregate Report PreparationRisk Management PlansMedDRA CodingIndividual Case HandlingSignal ManagementData AnalysisSafety Risk ManagementRegulatory SubmissionsSafety SurveillanceAudit Participation
Soft Skills
Exceptional CommunicationCross-Functional CollaborationStrategic ThinkingStakeholder EngagementSelf-Motivated
Certifications & Qualifications
Health Care Professional DegreePost-Graduate Training in Epidemiology
Industry Keywords
Biopharmaceutical IndustryClinical Study TeamsDrug Development ProcessesGVP GuidelinesICH GuidelinesNeurosciencePsychiatryNeurodegenerative Disease