Lead global pharmacovigilance strategy and safety governance.
Ensure compliance with FDA, EMA, ICH, and GCP standards.
Build and lead a high-performing pharmacovigilance organization.
Deciphera is a biopharmaceutical company focused on developing kinase inhibitors for cancer. The company fosters a culture of scientific excellence, accountability, and patient-focused decision making.
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.
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.
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.
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.
Oversee outsourced Medical Information Contact Center vendor, managing performance, governance, and compliance for medical inquiries, adverse event intake, and product quality complaints.
Partner with internal teams to integrate contact center workflows with Medical Affairs, Pharmacovigilance, and IT systems, ensuring seamless data transfer and regulatory adherence.
Ensure all operations are inspection-ready, maintain procedural documents, and deliver performance reporting to leadership.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. The company is headquartered in Radnor, Pennsylvania, and operates as a fully remote organization with a collaborative culture.