Senior Director Pharmacovigilance
Apply NowCompany: Emalex Biosciences, Inc.
Location: Chicago, IL 60629
Description:
PRIMARY ROLE:
The Sr. Director, Pharmacovigilance is responsible for the operational oversight of pharmacovigilance activities related to Emalex Biosciences investigational and marketed products. This role is responsible for engaging with a team that performs pharmacovigilance services as well as working cross-functionally to support any risk-management activities. The incumbent will ensure compliance with all company policies and applicable regulatory requirements.
DUTIES AND RESPONSIBILITIES:
Develop and maintain all relevant standard operating procedures and working practice documents related to the processing and reporting of individual case safety reports
Implement and provide ongoing oversight of the services provided by the pharmacovigilance vendor
Collaborate closely with the company Medical Directors in the assessment and medical review of serious adverse events reported with commercial and investigational products
Collaborate with pharmacovigilance vendor and internal stakeholders in the development, review, and approval of aggregate reports (e.g., PADER, IND Annual Report)
Develop and maintain Safety Data Exchange Agreements with global business partners
Organize and participate in all aspects of cross-functional Safety Review Committee (SRC) meetings
Develop and maintain company core safety information (CCSI) for company products
Develop and deliver adverse event and product complaint training for company employees and external service provider personnel
Participate in investigator meetings to train investigators and site personnel in the collection and reporting of adverse events
Provide ongoing oversight of the services provided by vendors conducting studies (registries) related to post marketing commitments
Work cross functionally to ensure inspection readiness; serve as subject matter expert during regulatory inspections
Interface with internal stakeholders including Clinical Operations, Clinical Development, Regulatory Affairs, Medical Affairs, Legal, and Quality Assurance as needed
Comply with all Corporate Policies, business rules, and contractual agreements as set out and communicated by the company pursuant to good business practice
Comply with all regulations and guidance relevant to Good Pharmacovigilance Practices, post marketing safety reporting, and IND safety reporting
Perform other duties as assigned by management
QUALIFICATIONS:
Bachelor's degree required; Advanced degree in health-care discipline strongly preferred.
Minimum of 8 years of Drug Safety/Pharmacovigilance experience in a pharmaceutical company with at least 5 years' experience with case processing, aggregate reporting, signal detection and/or risk management.
Breadth and depth of experience managing investigational and post marketing pharmacovigilance activities.
Detailed knowledge and experience using a global drug safety database (e.g., ARGUS) and medical terminology dictionary (e.g., MedDRA).
Detailed knowledge of current US and global pharmacovigilance regulations, guidance, and practice standards.
Experience with FDA PADE inspections and PV audit readiness preferred.
Experience in managing external pharmacovigilance service providers preferred.
Experience with targeted safety studies and non-interventional cohort studies including pregnancy registries, database studies, and REMS preferred.
An understanding of the drug development process, including clinical trial methodology and GCPs; ability to comprehend clinical study reports and interpret scientific data.
Demonstrated ability to work independently or in teams, and under compressed deadlines with limited supervision on routine assignments.
Strong verbal and written communication skills with the ability to communicate to colleagues, business partners, stakeholders and upper management across varied styles and cultures.
Strong computer, organizational, and analytical skills.
The annual base salary for this role is $290,000.00 - $310,000.00 This is a good faith estimate of the pay range for this position and offers will ultimately be determined based on various factors, including but not limited to, relevant work experience, skills, education, and certifications. As such, final compensation may fall outside of this range. This position will also be eligible for a discretionary bonus. Emalex Biosciences offers a comprehensive benefits package, including group medical, dental and vision insurance, emotional health support, 401k, short and long-term disability, life and AD&D insurance, and flexible spending accounts.
The Sr. Director, Pharmacovigilance is responsible for the operational oversight of pharmacovigilance activities related to Emalex Biosciences investigational and marketed products. This role is responsible for engaging with a team that performs pharmacovigilance services as well as working cross-functionally to support any risk-management activities. The incumbent will ensure compliance with all company policies and applicable regulatory requirements.
DUTIES AND RESPONSIBILITIES:
Develop and maintain all relevant standard operating procedures and working practice documents related to the processing and reporting of individual case safety reports
Implement and provide ongoing oversight of the services provided by the pharmacovigilance vendor
Collaborate closely with the company Medical Directors in the assessment and medical review of serious adverse events reported with commercial and investigational products
Collaborate with pharmacovigilance vendor and internal stakeholders in the development, review, and approval of aggregate reports (e.g., PADER, IND Annual Report)
Develop and maintain Safety Data Exchange Agreements with global business partners
Organize and participate in all aspects of cross-functional Safety Review Committee (SRC) meetings
Develop and maintain company core safety information (CCSI) for company products
Develop and deliver adverse event and product complaint training for company employees and external service provider personnel
Participate in investigator meetings to train investigators and site personnel in the collection and reporting of adverse events
Provide ongoing oversight of the services provided by vendors conducting studies (registries) related to post marketing commitments
Work cross functionally to ensure inspection readiness; serve as subject matter expert during regulatory inspections
Interface with internal stakeholders including Clinical Operations, Clinical Development, Regulatory Affairs, Medical Affairs, Legal, and Quality Assurance as needed
Comply with all Corporate Policies, business rules, and contractual agreements as set out and communicated by the company pursuant to good business practice
Comply with all regulations and guidance relevant to Good Pharmacovigilance Practices, post marketing safety reporting, and IND safety reporting
Perform other duties as assigned by management
QUALIFICATIONS:
Bachelor's degree required; Advanced degree in health-care discipline strongly preferred.
Minimum of 8 years of Drug Safety/Pharmacovigilance experience in a pharmaceutical company with at least 5 years' experience with case processing, aggregate reporting, signal detection and/or risk management.
Breadth and depth of experience managing investigational and post marketing pharmacovigilance activities.
Detailed knowledge and experience using a global drug safety database (e.g., ARGUS) and medical terminology dictionary (e.g., MedDRA).
Detailed knowledge of current US and global pharmacovigilance regulations, guidance, and practice standards.
Experience with FDA PADE inspections and PV audit readiness preferred.
Experience in managing external pharmacovigilance service providers preferred.
Experience with targeted safety studies and non-interventional cohort studies including pregnancy registries, database studies, and REMS preferred.
An understanding of the drug development process, including clinical trial methodology and GCPs; ability to comprehend clinical study reports and interpret scientific data.
Demonstrated ability to work independently or in teams, and under compressed deadlines with limited supervision on routine assignments.
Strong verbal and written communication skills with the ability to communicate to colleagues, business partners, stakeholders and upper management across varied styles and cultures.
Strong computer, organizational, and analytical skills.
The annual base salary for this role is $290,000.00 - $310,000.00 This is a good faith estimate of the pay range for this position and offers will ultimately be determined based on various factors, including but not limited to, relevant work experience, skills, education, and certifications. As such, final compensation may fall outside of this range. This position will also be eligible for a discretionary bonus. Emalex Biosciences offers a comprehensive benefits package, including group medical, dental and vision insurance, emotional health support, 401k, short and long-term disability, life and AD&D insurance, and flexible spending accounts.