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Director, Safety Scientist – Pharmacovigilance
MapLight Therapeutics, Inc.. Manage safety surveillance and signal detection activities (period review of aggregate safety data, safety surveillance team meetings, track signals and related documentation) .
Posted 5/6/2026full-timeCalifornia, Massachusetts • 🇺🇸 United StatesLead💰 $220,000 - $240,000 per yearWebsite
About the role
Key responsibilities & impact- 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.
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 with at least 3 years of direct 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 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.
Benefits
Comp & perks- Annual bonus opportunity
- Medical, dental, vision, life and AD&D insurance
- Short term and long term disability
- 401(K) plan with match
- Stock options
- Flexible non-accrual paid time off
- Parental leave
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
safety surveillancesignal detectionsafety data reviewaggregate reportsrisk management plansMedDRAdrug codingclinical studyregulatory submissionsdata analysis
Soft Skills
communicationcross-functional collaborationstrategic thinkingproblem-solvingdependabilityself-motivationconstructive dialoguestakeholder engagementadaptabilityteamwork
Certifications
RNBSNPharmDMasters in biomedical sciencesPhD in biomedical sciencesGVP certificationICH guidelines trainingpharmacovigilance certificationclinical research certificationdrug safety certification