Senior Medical Director, Pharmacovigilance
MapLight Therapeutics, Inc.
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $319,000 - $375,000 per year
Job Level
About the role
- Lead product safety surveillance and oversee evolving safety and benefit-risk profiles for assigned products.
- Lead cross-functional safety management team (SMT) for assigned products, and responsible for the on-going assessment of benefit-risk profiles and related actions during the product life cycle.
- Review safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process as well as post marketing for assigned products.
- Responsible for conducting signal detection activities, monitoring, evaluation, interpretation and appropriate management and communication of safety information
- Represent pharmacovigilance on cross-functional product/project teams including review of safety sections of protocols, investigator brochures, informed consent forms, and other documents with safety content.
- Responsible for strategy and key content of Risk Management documents (DRMPs, RMPs, REMS) and regulatory responses.
- Provide strategy and guidance to safety risk management scientists in writing of periodic reports for assigned products; provide medical interpretation, review and approval.
- Responsible for up-to-date representation of safety information in Company Core Data Sheet and Investigator Brochure, and other labeling documents.
- Perform the medical review of all adverse event reports for seriousness, expectedness and causality.
- Coach, mentor and manage safety scientists supporting the surveillance activities for assigned products.
- Represent Pharmacovigilance function in committees and activities both internally and externally when appropriate.
Requirements
- MD or equivalent with 3-5 years of relevant clinical experience
- Preferred: Board Certified/Board Eligible in Neurology or psychiatry
- Minimum 10 years’ industry experience, within Drug safety/Pharmacovigilance with investigational and/or marketed products
- Preferred: experience in NDA/IND submissions in neuroscience, psychiatry or neurodegenerative therapeutic area
- Proven experience in safety data analysis, signal management, and benefit-risk evaluation
- Working knowledge of safety databases (Argus, ArisG/LifeSphere Safety, or similar)
- Demonstrated ability to develop and implement drug safety strategies and risk management plans
- Proven experience with authoring or contributing to clinical study and regulatory submission documents
- Working knowledge of relevant local and global regulatory requirements and guidance documents
- Able to lead in a cross functional setting and work collaboratively with internal and external partners in a fast-paced environment
- 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.
- Effective oral and written communication skills.
- Highly motivated, self-driven and dependable.
- Committed to MapLight's Core Beliefs and Values.
Benefits
- annual bonus opportunity
- medical insurance
- dental insurance
- vision insurance
- life and AD&D insurance
- short term disability
- long term disability
- 401(K) plan with match
- stock options
- flexible non-accrual paid time off
- parental leave
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
safety data analysissignal managementbenefit-risk evaluationdrug safety strategiesrisk management plansclinical study documentsregulatory submission documentsadverse event report reviewmedical interpretationsafety information management
Soft Skills
leadershipcollaborationcommunicationmentoringcoachingstrategic thinkingadaptabilityconstructive dialoguedependabilitymotivation
Certifications
MDBoard Certified in NeurologyBoard Certified in Psychiatry