The Role:

Reporting to the Senior Vice President, Pharmacovigilance, the Senior Director, Drug Safety and Pharmacovigilance Operations is responsible for the operational management and oversight of case processing activities performed internally and externally by vendors (CROs), expedited safety reporting and partner data exchange. The successful candidate will be responsible for ensuring all ICSR processing in compliance with regulatory requirements and corporate and departmental procedures. This position requires ability to influence without directly managing and partner with internal and external colleagues in matrix teams and with senior management, including supervision and management of internal safety operations personnel as the department expands.

Responsibilities:

• Subject matter expertise on safety operations and overall data quality during audits/inspections.
• Continuous improvement and maintenance of a robust oversight plan related to internal and external case processing (e.g., monitoring reports, quality evaluations).
• Functional support / input to set up vendor relationships (e.g., business requirements, vendor selection, contract details, vendor oversight / safety management plans).
• Partner with PV Quality, Compliance and Infrastructure in the generation, review and approval of governing documents, such as SOPs, Operating Guidelines and Safety Management Plans, as necessary, and ensure operational implementation.
• Partner with PV Quality, Compliance and Infrastructure in the review of PV vendor metrics reviews; develop and implement CRO case processing vendor improvement plans, as needed, evaluate outcomes of implemented improvement plans.
• Exchange of safety data with partners, as required.
• Ensure timely submission of expedited safety reports and other external submissions through effective vendor management and performance metrics review. Partner with PV Quality, Compliance & Infrastructure to identify CAPAs required to address late reporting. Partner with PV Quality, Compliance & Infrastructure to maintain current PV regulatory intelligence in the company safety database.
• Provide PV operational support to clinical trial study teams; Partner with PV Quality, Compliance and Infrastructure for data generation required to support the study teams, to develop and monitor adverse event reporting site performance metrics.
• Develop adverse event receipt and processing structure in preparation for product launch; partner with medical affairs to identify post-marketing vendors and reporting strategy.
• Establish and maintain a globally compliant, industry standard PV Safety Database to enable collection, processing and reporting of adverse events to competent authorities for both pre and post authorization setting.
• Partner with PV Quality, Compliance and Infrastructure on activities required in preparation for product launch.

Competencies Include:

• Strong written/verbal communication skills.
• Ability to work in a collaborative environment and build effective working relationships across the organization, and with external stakeholders/vendors
• Detail and process orientated, with excellent project management, problem solving, and organization skills.
• Ability to think critically with strong attention to detail.
• Demonstrated project management and prioritization capabilities

 Qualifications:

• Bachelor’s level degree in nursing, pharmacy, or other health care related profession or life sciences or in science and engineering required.
• Master’s or Doctorate level degree in health care related profession preferred but not essential
• 8-10 years in Drug safety/Pharmacovigilance in pharmaceutical industry setting or the equivalent.
• Minimum 2 years’ experience working with CROs, vendors, and relationship management preferred.
• Ability to work independently and productively and set priorities across multiple projects with little supervision.
• Exhibits leadership skills that promotes team collaboration, foster open dialog, maintains an inclusive collaborative environment, keeps a team focused on a common goal and maintains positive momentum through difficulties.
• Proven ability to lead a cross-functional, matrixed team.
• Expert knowledge of FDA and EU legislation and ICH PV guidelines.
• Prior NDA / MAA experience preferred.
• Successful leadership / senior level experience in global pharmacovigilance operations with pre-approved products.
• Experience with selection and working with contract service providers for case processing, aggregate reporting and quality management activities.
• Extensive experience in performance management of PV systems.
• Experience with regulatory inspections and company audits including MHRA/EMA PV inspections.