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.
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 day-to-day management of third-party vendors throughout clinical study lifecycle.
Develop and implement vendor oversight plans and monitor performance through KPIs and governance meetings.
Facilitate cross-functional collaboration to resolve issues and ensure compliance with GCP and regulatory requirements.
The company is a clinical research organization that manages clinical trials and third-party vendors. The team size is not specified, but the culture is collaborative and quality-focused.
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.
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 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.
Evaluate RFPs and contribute to bid strategies for clinical supply proposals.
Collaborate with business development, contracts, proposals, and operations teams to align budgets and assumptions.
Manage multiple priorities in a fast-paced international environment while maintaining quality and accuracy.
This partner company operates in the clinical research and supply chain environment, supporting high-quality proposals and clinical trial supply management. It provides a fully remote, supportive working environment with a focus on employee health and wellbeing, offering exposure to international projects and collaboration with cross-functional teams.
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.
Prepare and manage clinical trial submissions to Competent Authorities and Ethics Committees for initial and subsequent approvals.
Collect, review, and maintain essential documents for site activation, ensuring compliance with ICH-GCP and local regulations.
Act as Subject Matter Expert, mentoring less-experienced staff on site start-up activities and regulatory requirements.
Precision Medicine Group is a life sciences organization that provides clinical trial and regulatory services to biopharmaceutical companies. They are expanding their presence in Latin America and foster a collaborative, fast-paced culture focused on precision medicine.
Critically evaluate scientific literature and produce accurate regulatory documents.
Manage writing assignments across multiple projects and ensure timely delivery.
Work directly with clients and multidisciplinary teams on regulatory submissions.
A partner company in the pharmaceutical, biotechnology, and medical device sectors is hiring a Senior Medical Writer. The company offers a fully remote environment and opportunities to work on a broad portfolio of clinical and regulatory documents.
Manage relationships with hospitals, imaging centers, and healthcare organizations to support student placements.
Develop and maintain communication cadences, lead partner check-ins, and handle sensitive situations.
Reactivate inactive partners and build new clinical partnerships through outbound prospecting.
They build and strengthen relationships between healthcare organizations and an innovative education program. They operate as a fully remote organization focused on expanding healthcare training capacity.