Director Global Safety and PV Operations

We are seeking a Director, Global Safety and Pharmacovigilance Operations. This position is responsible for safety/pharmacovigilance operational activities related to clinical use of assigned Apogee products. Accountable for the successful oversight and execution of deliverables related to case management and aggregate reports. This position ensures individual safety reports from clinical trial sources are collected, managed, and reported according to Apogee’s SOPs and global adverse event regulations and guidelines. Manages contract service providers and ensures appropriate documentation is in place to support activities. Supports aggregate report production and ensures compliance with timely reporting of safety information to Regulatory Authorities to meet regulatory requirements.

This role is critical to support the overall global safety surveillance program to ensure the proper management of the benefit risk profile of Apogee’s products. It is equally important to ensure compliance with global regulatory requirements and Apogee’s policies and standards.

Key Responsibilities 

• Manages all operational aspects of pharmacovigilance
• Proactively oversees creation and continuous improvement of adverse event reporting and management processes on a global scale, including the oversight of the case management and regulatory submissions activities
• Leads safety review meetings and oversees global signal detection and surveillance activities for assigned Apogee products
• Partners with vendors for resolution of safety operational issues and questions, identifying vendor training needs and opportunities for improvement and ensuring implementation in collaboration with Apogee stakeholders
• Accountable for effective oversight of outsourced operational activities, measuring vendor performance through Key Performance Indicators/Metrics according to Apogee standards and contracted Service Level Agreements(s)
• Oversees the appropriate management of safety management plans (SMP) and other operating procedures with business partners as required
• Provide direction and leadership regarding safety vendor management
• Assist in management of all critical departmental timelines and with budgets for internal and external spend
• Plan and oversee the implementation of database reconciliation in collaboration with Data Management and Apogee business partners as required
• Ensure appropriate documentation by identifying and preparing required written procedures
• Provide operational input into PV SOPs and reviews SOPs from other functions
• Maintain aggregate report schedule, ensure proper SOPs are in place and current to support aggregate report production
• In collaboration with Regulatory Affairs, provide information to be submitted to Regulatory Authorities, maintain and update regulatory reporting rules, ensure timely submission of expedited safety reports, and ensure that submission information is tracked in the safety database
• As required, participate in strategic planning, workflow development, standard operating procedure updates, development & compliance, audits, data analysis and clinical team meetings
• Identify opportunities for process efficiencies and participate in process improvement initiatives
• Provide support to the Quality team and support product complaint activities as needed
• Ensure compliance with FDA regulations and ICH guidelines to meet all regulatory drug safety and pharmacovigilance reporting requirements

Ideal Candidate 

• Bachelor’s degree in life sciences or related area, Master’s degree or higher preferred
• Minimum 8 years of pharmaceutical experience with a demonstrated focus in PV operations and compliance
• At least 4 years of experience in leading cross-functional teams and/or PV related deliverables and initiatives
• Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA
• Thorough knowledge of relevant FDA and International Conference on Harmonization (ICH) guidelines required, including Good Clinical Practices (GCP) guidelines
• Working knowledge and experience with European pharmacovigilance regulations preferred.
• Thorough understanding of Individual Case Safety Reports (ICSR) processing operations required, including working with outsourced vendors and Contract Research Organizations as well as all steps through case receipt, case processing, medical review, and regulatory submission, issuing follow up queries, etc.
• Solid knowledge of safety surveillance and aggregate report requirements for clinical trials.
• Demonstrated technical, administrative, and project management capabilities
• Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills
• Adaptable to changing priorities
• Proven ability to work in a cross-functional team environment
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Position requires approximately 15% travel to All Team meetings and functional meetings

The anticipated salary range for candidates for this role will be $210,000-$245,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.