[Hiring] Sr. Medical Director, Pharmacovigilance @MapLight Therapeutics
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.
Role Description
The Senior Medical Director, Pharmacovigilance will lead the medical safety evaluation and benefit-risk assessment for products throughout their lifecycle with focus on patient well-being and compliance and applicable regulatory requirements.
• 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, responsible for the ongoing 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.
• Conduct 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.
We consider these behaviors we seek in all ML employees:
• You can participate and work effectively with multiple cross-functional teams.
• You have strong interpersonal skills and understanding relationships are key to being successful.
• You are a leader. Teams love working with you, and you are someone who takes pride in mentoring and supporting the careers of others.
• You’re a team player who is willing to roll up your sleeves and get the job done.
Qualifications
• 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.
Requirements
• This is a remote US position.
• Ability to travel as needed (up to 10%) for corporate and departmental meetings.
Benefits
• 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
Salary Range
$319,000 - $375,000 USD
EEOC Statement
MapLight Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Apply Now
Apply Now
Role Description
The Senior Medical Director, Pharmacovigilance will lead the medical safety evaluation and benefit-risk assessment for products throughout their lifecycle with focus on patient well-being and compliance and applicable regulatory requirements.
• 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, responsible for the ongoing 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.
• Conduct 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.
We consider these behaviors we seek in all ML employees:
• You can participate and work effectively with multiple cross-functional teams.
• You have strong interpersonal skills and understanding relationships are key to being successful.
• You are a leader. Teams love working with you, and you are someone who takes pride in mentoring and supporting the careers of others.
• You’re a team player who is willing to roll up your sleeves and get the job done.
Qualifications
• 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.
Requirements
• This is a remote US position.
• Ability to travel as needed (up to 10%) for corporate and departmental meetings.
Benefits
• 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
Salary Range
$319,000 - $375,000 USD
EEOC Statement
MapLight Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Apply Now
Apply Now