Sr. Medical Director, Pharmacovigilance

What You’ll Do: 

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. This person will lead cross-functional safety management team (SMT) and collaborate with other members Clinical Development and Medical Affairs (CDMA), contract research organizations (CROs), and drug development collaborators/partners to ensure that all clinical safety and benefit-risk assessment is performed adequately for assigned products. Reporting to the Vice President, Pharmacovigilance, the Senior Medical Director will oversee cross-functional teams and may have direct reports

 Responsibilities:

• 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.

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 Ma