Manager/Sr. Manager, PV Operation - Oncology Biotech

Systimmune; Princeton (NJ); On-site; USD 120,000 - 190,000; Full time

Benefits offered by this job

Comprehensive benefits package

Job summary

SystImmune in Princeton, NJ is seeking a Pharmacovigilance Operations support role working with the Senior Director to manage PV activities and ensure regulatory compliance across vendors.

The role collaborates with internal teams and external partners to oversee SAE processing, safety reporting, and CAPA, contributing to a robust Drug Safety program.

Qualifications

• Minimum 5-7 years pharmacovigilance experience in a pharmaceutical, biotechnology or related environment.
• Minimum 3 years of experience managing daily execution of pharmacovigilance (PV) operations
• Minimum 3 years of experience processing SAEs including case triage, data entry, coding review and narrative writing
• Minimum 3 years providing drug safety operations support for external submissions, signal detection, and risk management planning activities
• Minimum 3 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 overseeing compliance with PV regulations, PV agreements, and internal SOPs, including analyzing and mitigating compliance risk

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.

Skills

PV operations management

SAE processing

Data entry

Coding review

Narrative writing

Signal detection

Risk management planning

External submissions support

Regulatory inspections support

Education

Bachelor’s degree in healthcare

RPh/PharmD/PhD degree

Job description

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.

Summary:

The role is responsible for supporting the Senior Director of Pharmacovigilance (PV) Operations with elements of the pharmacovigilance function. This includes overall accountability for vendor management/oversight; training; business integration; Quality Management System (QMS); Safety Data Exchange Agreements (SDEAs); PV Safety database, and CAPA management. This individual will manage day-to-day operational activities of Systimmune’s Pharmacovigilance function and ensure that projects comply with standard operating procedures (SOP), policies, best industry standards, and applicable regulations.

The role will be involved in working cross-functionally with internal departments/key stakeholders and external partners on pharmacovigilance-related matters.

Responsbilities:

• 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

• Bachelor’s degree in healthcare or a BSN/RN degree with a minimum of 5-7years pharmacovigilance experience in a pharmaceutical, biotechnology or related environment. An RPh, PharmD, or PhD degree may be considered with 3-5 years of relevant experience
• Minimum 3 years of experience managing daily execution of pharmacovigilance (PV) operations
• Minimum 3 years of experience processing SAEs including case triage, data entry, coding review and narrative writing
• Minimum 3 years providing drug safety operations support for external submissions, signal detection, and risk management planning activities
• Minimum 3 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 3 years providing strategic oversight of pharma industry CRO and/or CMO vendors, managing both quality and compliance, and providing training and mentoring.