Careers - Pharmacovigilance - Associate Director/Director of PV Operations

Associate Director/Director of PV Operations

Redmond

Job Summary:

This role will report to the VP, Head of Pharmacovigilance.
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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

The hiring pay range for this position is $150,000 - $250,000 per year based on skills, education, and experience relevant to the role.

SystImmune 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). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or 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. SystImmune offers a comprehensive benefits package.

SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply. To be considered, please send your CV and cover letter to [email protected]