Associate Director/Director of PV Operations

This role will report to the VP, Head of Pharmacovigilance.
This individual will manage day-to-day operational activities of SystImmune’s Pharmacovigilance function and ensure that projects comply with standard operating procedures, policies, best industry standards, and applicable regulations.
Responsibilities

• Coordinate the daily management and execution of drug safety (DS) and pharmacovigilance (PV) operations.
• Work with compliance with regulations, PV agreements, and internal SOPs.
• Represent the Drug Safety and Pharmacovigilance departments on clinical development teams.
• Oversee SAE (Serious Adverse Event) processing by outsourced vendors, and review and monitor compliance operations.
• Execute strategies to achieve and maintain the desired level of quality including, by analyzing and mitigating compliance risk.
• Process SAEs include case triage, data entry, coding review and narrative writing.
• Provide safety operations support for external submissions, signal detection, and risk management planning activities.
• Facilitate the preparation of periodic safety reports (e.g., DSUR, PSUR).
• Ensure compliant exchange of safety data between SystImmune and its partners.
• Work with the quality management system in Drug Safety to ensure department standards are met, including training requirements, monitoring performance, implementing continuous improvement actions, and good documentation practices.
• Work with the QA department to maintain a state of high PV inspection readiness across all regions/countries.
• Collaborate with contract service providers for case processing, aggregate reporting, and quality management activities.
• Conduct performance management of PV systems.
• Support the performance of root cause analysis of deviations relevant to PV systems.
• Participate in regulatory inspections and company audits including FDA/MHRA/EMA PV inspections.
• Prepare responses to audit findings that concern the PV department.
• Manage reconciliation activities with other departments within the company and vendors.
• Provide project management support to the NDA/MAA submission activities and prepare safety data submission.
• Support the cross - functional teams in patient narratives efforts.
• Participate in the bid defense process.
• Provide strategic oversight of vendors.
• Manage both quality and compliance of assignments, including training and mentoring.

Qualifications

• Master’s degree in QA and Regulatory Affairs or related pharmaceutical/science field (or foreign equivalent degree)
• Minimum 5 years of experience managing daily execution of pharmacovigilance (PV) operations
• Minimum 5 years of experience processing SAEs including case triage, data entry, coding review and narrative writing
• Minimum 5 years providing drug safety operations support for external submissions, signal detection, and risk management planning activities
• Minimum 5 years working with Drug Safety quality management systems to ensure compliance with department standards and training requirements, monitoring performance, implementing continuous improvement actions, and ensuring good documentation practices
• Minimum 3 years of experience overseeing compliance with Pharmacovigilance (PV) regulations, PV agreements, and internal SOPs, including analyzing and mitigating compliance risk, providing safety operations support for external submissions, signal detection, and risk management planning activities,
• Minimum 3 years of experience preparing safety reports (e.g., DSUR, PSUR)
• Minimum 3 years conducting performance management of PV systems and performing root cause analysis of deviations relevant to PV systems
• Minimum 3 years conducting regulatory DSPV inspections and company audits including MHRA/EMA PV inspections, and preparing responses to audit findings
• Minimum 5 years providing strategic oversight of pharma industry CRO and/or CMO vendors, managing both quality and compliance, and providing training and mentoring.
• Minimum 3 years of experience participating in the bid defense process

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