Senior Director, Pharmacovigilance
Stoughton, MA, USA | Collegium Pharmaceutical, Inc.
Industry:Pharmaceutical / Biotech
Job Description:128 people have viewed this job
The Sr. Director, PVG will be responsible for building, developing and leading a Pharmacovigilance department for the evolving needs of Collegium. They will report to the Chief Medical Officer.
Build and lead the company’s drug safety and pharmacovigilance process.
Manage compliance with standard operating procedures, regulatory safety and pharmacovigilance in compliance with national and international regulations, such as the Food and Drug Administration (FDA) and World Health Organization, global, regional and country regulations for the reporting of adverse events to regulatory agencies.
Direct, control and implement all pharmacovigilance activities according to in-house specifications as well as FDA, EU and international regulations;
Provide expert analysis and evaluation of external pharmacovigilance information;
Lead pharmacovigilance evaluation of business development opportunities
Communicate with US, European, and other international regulatory agencies;
Develop and maintain current pharmacovigilance knowledge and ensure that staff is aware of new and existing relevant procedures, guidance, and regulations;
Coordinate the development of internal safety SOP/policies
Ensures the uniform and timely processing of adverse event reports.
Interface with internal and external collaborators to develop programs and processes to meet regulatory reporting requirements.
Oversee the development and preparation of reports for company management as well as external regulatory agencies.
ongoing safety surveillance on company products. Lead, manage and conduct
Oversee the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications, product labeling/package inserts and other reports as necessary.
Participate in oversight of ongoing clinical trials and lead preparation of new drug applications with respect to drug safety.
Establish and manage the department budget and ensure that the department operates cost-efficiently.
Demonstrate cross-functional expertise and thrives in a highly complex environment.
Demonstrate strong analytical thinking, organizational and communication skills.
Work with diverse stakeholders and builds strong, collaborative relationships. Manages competing agendas and priorities across different functional departments.
Sets direction and focus by leveraging organizational abilities and proactive planning.
Advanced degree in a scientific discipline and significant experience within the pharmacovigilance space including both post-marketing and pre-NDA activities.
Significant experience as well as background dealing with the FDA
Substantial experience in all aspects of pharmacovigilance, including standard operating procedures, regulatory safety and pharmacovigilance in compliance with national and international regulations A thorough understanding of relevant guidance and regulations and requirements;
Has exceptional qualitative and analytical/quantitative skills.
Demonstrates outstanding leadership capabilities, including employee coaching, objective setting, and professional development.
Collaborates with diverse stakeholders and builds strong, cross functional relationships.
Manages competing agendas and priorities.
Consistently demonstrates strategic thinking about business initiatives with an entrepreneurial spirit.
Exceptional verbal and written communication skills.
Excellent organizational, interpersonal, communication and negotiation skills
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