Sr. Director Pharmacovigilance in Chicago, Illinois at Emalex Biosciences, Inc

PRIMARY ROLE:

The Sr. Director, Pharmacovigilance is responsible for the operational oversight of pharmacovigilance activities related to 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.