Manager​/Senior Manager, PV Operation

Overview

Syst Immune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). Syst Immune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, Syst Immune has a robust preclinical pipeline of potential cancer therapeutics in the discovery and IND-enabling stages, representing cutting-edge biologics development.

We offer an opportunity for you to learn and grow while making significant contributions to the company s success.

We are seeking a Manager or Senior Manager, Pharmacovigilance (PV) Operations to support the Senior Director of PV Operations in key areas of the pharmacovigilance function. This role will have accountability for vendor oversight, training, business process integration, Quality Management System (QMS) activities, Safety Data Exchange Agreements (SDEAs), safety database management, and CAPA coordination. This individual will manage the day-to-day operational activities of Syst Immune’s Pharmacovigilance function, ensuring that all projects adhere to standard operating procedures (SOPs), internal policies, industry best practices, and applicable global regulations.

The role will also work cross-functionally with internal teams and key stakeholders, as well as external partners, to support a wide range of pharmacovigilance-related activities.

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 including 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 Syst Immune 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

• Bachelor’s degree in healthcare or a BSN/RN degree with a minimum of 5-7 years pharmacovigilance experience in a pharmaceutical, biotechnology or related environment. An RPh, Pharm
  
  D, or PhD degree may be considered with 3 years of relevant experience
• At least 3 years minimum of experience in the following areas:
• Managing daily execution of pharmacovigilance (PV) operations
• Processing SAEs including case triage, data entry, coding review and narrative writing
• Providing drug safety operations support for external…