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.
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.
Youre a team player who is willing to roll up your sleeves and get the job done.
Requirements / 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 Companys stakeholders based on equality and mutual respect.