icsr

Associate Director. ICSR Managing the assigned ICSR Management Unit effectively Ensuring adequate resources within the ICSR project teams to achieve the maximum level of productivity and utilisation Setting productivity targets for ongoing projects and reviewing proposed target updates as required Based on reports and analyses, defining the appropriate...

Associate Director overseeing an ICSR Management Unit at a life-sciences CRO, responsible for team leadership, resource optimization, productivity management, and pharmacovigilance operations across assigned projects. Responsibilities Manage ICSR Management Unit, including resource allocation and productivity targets for project teams Oversee ICSR Leads...

Company Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and...

Associate Director overseeing an ICSR Management Unit at a life-sciences CRO, responsible for team leadership, resource optimization, productivity management, and pharmacovigilance operations across assigned projects. Responsibilities Manage ICSR Management Unit, including resource allocation and productivity targets for project teams Oversee ICSR Leads...

Ascendis Pharma is seeking a Director of the ICSR Management Team in Palo Alto to lead pharmacovigilance operations and ensure timely ICSR processing in alignment with ICH-GCP and Health Authority requirements. The role oversees a team of ICSR leads, drives strategic planning with Global PV Operations, collaborates cross-functionally, and maintains data...

Senior Specialist, Global ICSR Management BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. Language...

Manager, ICSR Processes And SystemsThe Manager, ICSR Processes and Systems is accountable for providing ICSR processing subject matter expertise and ensure compliance of global PV regulations and ICH standards of ICSR handling within our technology systems, (e.g., safety database) used by Global Case Management.What You'll DoReview and assess regulatory...

Senior Specialist, Global ICSR Management BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. Language...

IDEAYA Biosciences, Inc. is seeking a Medical Director of Patient Safety and Pharmacovigilance to lead medical review of ICSRs in oncology and to oversee the global pharmacovigilance program. The role is based in South San Francisco with onsite four days per week and some work-from-home flexibility. You will partner with Safety Operations and external PV...

Agios Pharmaceuticals is seeking an Associate Director, Medical Review Lead to join the team in Cambridge, MA. This role involves oversight of medical review for Individual Case Safety Reports (ICSRs) to ensure compliance and quality of safety data. The successful candidate will have substantial experience in drug safety and vendor oversight. We offer...

Vertex Pharmaceuticals in Boston seeks Associate Director, Global Patient Safety ICSR TA Lead to oversee global ICSR processing and external vendor management within a Therapeutic Area. You will lead TA ICSR operations, ensure regulatory compliance, and drive KPI-based vendor oversight to deliver timely high-quality cases. You will mentor staff across PV...

Scorpion Therapeutics is seeking an Associate Director, Global Patient Safety ICSR Therapeutic Area Lead to oversee global ICSR processing and external PV partner management within a specified therapeutic area. You will lead ICSR operations, ensure regulatory compliance, develop best practices including automation, mentor staff, manage audits/inspections,...

Regeneron seeks an Associate Director to lead Pharmacovigilance Case Operations, directing global case processing and ICSR quality across development programs and marketed products. The role emphasizes CAPA ownership, audits, and timely regulatory submissions, with site-based work in Warren, NJ and occasional travel. You will mentor staff, manage vendor...

Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues. Guided by our core values of...

Nurix Therapeutics is seeking an Associate Director of Pharmacovigilance Operations to lead PV operations across product lifecycles, from FIH to post-marketing. You will own ICSR management, RSI tracking, and regulatory submission oversight, while guiding cross-functional teams and vendor partners to ensure quality and compliance. You will contribute to PV...

Genentech is seeking a Pharmacovigilance professional to monitor drug safety, evaluate adverse events, and ensure data integrity in the global safety database. The role includes leading quality reviews of ICSRs, preparing executive summaries on quarterly trends, and driving continuous PV process improvements. The position requires a Health Care Professional...

CRISPR Therapeutics, Inc. in Boston, MA is hiring a Senior Specialist, Drug Safety to support ICSR processing and ensure high-quality safety cases. The role reports to Head of PV Ops and requires independent, detail-oriented work in a fast-paced Biotechnology environment. You will manage data entry, QC the ICSRs, ensure timely submissions to regulators and...

Ascendis Pharma is seeking a Director of the ICSR Management Team in Palo Alto to lead pharmacovigilance operations and ensure timely ICSR processing in alignment with ICH-GCP and Health Authority requirements. The role oversees a team of ICSR leads, drives strategic planning with Global PV Operations, collaborates cross-functionally, and maintains data...

Regeneron seeks an Associate Director to lead Pharmacovigilance Case Operations, directing global case processing and ICSR quality across development programs and marketed products. The role emphasizes CAPA ownership, audits, and timely regulatory submissions, with site-based work in Warren, NJ and occasional travel.You will mentor staff, manage vendor...

Ascendis Pharma, based in Palo Alto, CA, seeks a Medical Assessment and Signal Detection Lead to review and approve ICSSRs from trials and post-marketing, perform signal detection, and support PV operations. You will collaborate with Medical Monitors and program safety leads to ensure high‑quality safety assessments. The role requires an MD and 5+ years in...