Lead global Pharmacovigilance Operations, Quality & Compliance strategy to ensure scalable, inspection-ready systems.
Oversee case processing, vendor governance, PSMF, quality systems, audits, and regulatory inspections.
Build and mentor a global team, collaborating cross-functionally to support portfolio growth and commercialization.
Ultragenyx is a biopharmaceutical company focused on developing life-changing treatments for rare diseases. They foster a supportive and inclusive culture of learning and growth, aiming to be an organization where employees can thrive personally and professionally.
Lead quality assurance activities to support patient safety and pharmacovigilance compliance across global operations.
Plan, conduct, and manage pharmacovigilance audits, CAPA programs, and regulatory inspection readiness activities.
Collaborate with cross-functional teams including clinical development, regulatory affairs, and medical affairs to maintain robust quality systems.
This company is a science-driven healthcare organization focused on pharmacovigilance and patient safety. They operate in a collaborative, global environment committed to operational excellence and meaningful healthcare impact.
Lead global pharmacovigilance audits, regulatory inspections, and readiness planning.
Oversee issue management, deviations, root-cause analysis, and CAPA activities.
Develop and manage the global pharmacovigilance training program and procedural documentation.
Our partner is a fast-growing biopharmaceutical company focused on improving outcomes for patients with severe autoimmune diseases. It offers a collaborative environment with opportunities for professional growth and leadership development.
Author aggregate safety reports including PBRER, PSUR, DSUR, and others for submissions to health authorities.
Coordinate with stakeholders to obtain data, plan timelines, and ensure timely delivery of reports.
Mentor junior team members, conduct training, and maintain awareness of regulatory guidelines.
ClinChoice partners with pharmaceutical, medical device, and consumer care companies to accelerate clinical trials and ensure product safety. With a global delivery network spanning multiple countries, they provide expertise in clinical operations, biometrics, pharmacovigilance, and more.
Lead the PV Medical Writing function, ensuring high-quality, compliant, and timely deliverables.
Manage and develop the PV Medical Writing team, fostering performance, engagement, and professional growth.
Drive quality, compliance, inspection readiness, and continuous improvement initiatives, including oversight of SOPs, KPIs, audits, and regulatory inspections.
PrimeVigilance is a global pharmacovigilance specialist helping clients navigate complex regulations while keeping patient safety at the center of every decision. With teams across Europe, North America, South America, Asia and Australia, we foster a culture of kindness, flexibility, growth, and belonging.
Serves as main point of contact for adverse event questions and reviews in safety and clinical databases.
Performs quality control checks and finalization of cases in the Argus database.
Assists in oversight of case processing vendor and preparation of safety reports for regulatory agencies.
Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies for blood cancer patients. The company maintains a start-up culture of camaraderie and leadership by example.
Lead client-facing safety projects and serve as the primary point of contact for pharmacovigilance services.
Manage project scope, timelines, and deliverables while coordinating activities across PV teams.
Provide pharmacovigilance expertise including ICSR processing, aggregate reporting, and quality review.
Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. It uses a shortlisting process to ensure fair and objective application review, and the final hiring decisions are made by the partner company.
Independently manage ICSR triage, case processing, and quality control for global safety reports.
Perform SAE reconciliation between safety and clinical databases, ensuring compliance with timelines.
Support team development through training, onboarding, and process improvement initiatives.
This company is a partner organization focused on global pharmacovigilance operations. It is a fast-growing, internationally focused company with a collaborative culture emphasizing teamwork, excellence, and continuous improvement.
Provide support to other activities undertaken by the project team on behalf of the client and the company.
Create and maintain project-specific KPIs for contracted ICSR activities, proposing process changes to the ICSR Operational Lead.
Manage ICSR deviations, review trackers and timesheet data for accuracy, and operate as the assigned team SME.
PrimeVigilance is a global pharmacovigilance specialist that helps clients navigate complex regulations while keeping patient safety at the center of every decision. The company operates across Europe, North America, South America, Asia, and Australia in a culture built on kindness, flexibility, growth, and belonging.
Support and contribute to global regulatory strategies to expedite development and mitigate risks.
Plan, prepare, and coordinate regulatory documents for submissions to global health authorities (INDs, BLAs, MAAs, etc.).
Collaborate with cross-functional teams and support interactions with FDA and other Health Authorities.
Immunovant, Inc. is a clinical-stage immunology company developing targeted therapies for autoimmune diseases. As a rapid-growth biotech startup, it fosters a dynamic, fast-paced, and entrepreneurial environment.
Leads quality compliance, risk management, and vendor oversight programs to support late-stage development.
Manages inspection readiness, data integrity assessments, and regulatory authority interactions across GxP.
Provides senior-level quality judgment and drives risk-based decisions in a dynamic environment.
Braveheart Bio is a clinical-stage biopharmaceutical company developing therapies for hypertrophic cardiomyopathy and other cardiovascular diseases. It has a proven leadership team, strong financial foundation, and a high-value late-stage asset, offering an opportunity for mission-driven professionals.
Manage the intake, review, analysis, and reporting of Individual Case Safety Reports (ICSRs) and support Clinical Events Committees and Data Monitoring Committees.
Co-author and maintain study-specific safety documents and prepare aggregate safety reports for regulatory submission.
Collaborate with sponsors, study teams, and cross-functional partners to ensure data quality and compliance with GCP and GVP standards.
This partner company delivers high-quality safety services across clinical research and medical device programs. They foster a collaborative, detail-oriented environment with a focus on compliance and patient outcomes.