Associate Director, Drug Safety Operations

Need Independent candidates only (USC/ GC). The Senior Manager, PV Operations will support global drug safety activities across clinical development and post-marketing programs. Minimum 5 years of biotech/pharma experience, including 3+ years in drug safety/ Pharmacovigilance. Experience with CRO/vendor oversight, global PV operations, and strong knowledge...

A biotechnology company based in Waltham, MA, is looking for a Senior Manager in PV Operations to lead global drug safety activities. The ideal candidate will have over 5 years' experience in biotech or pharma, with a focus on drug safety and vendor oversight. Responsibilities include monitoring vendor performance and ensuring compliance with regulatory...

Associate Director, Drug ProductAt Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera's mission to advance novel therapies for...

Job#: 3015211 Job Description: Our Waltham based pharmaceutical client is seeking an Associate Director, Safety Systems to manage and maintain a global Argus drug safety platform. This role will oversee end‑to‑end safety system activities including reporting, E2B transmissions, and system interfaces. The ideal candidate will combine deep...

OverviewPeak Performers has partnered with a pharmaceutical company to assist in their search for a hybrid Drug Safety Senior Specialist in Waltham, MA. In this position, you will participate in protocol design, safety CRF development, safety monitoring plan, support of DSMB activities, coding review as well as SAE reconciliation...

Company Overview:Mythic Therapeutics is a privately held, clinical stage product-platform company building a pipeline of best-in-class antibody drug conjugates (ADCs) exhibiting a combination of unprecedented efficacy and therapeutic index. The Company’s FateControl™ engineering technology dramatically enhances ADC uptake in tumor cells with less impact...

Overview:We are currently seeking an Associate Director to join Technical Operations as process expert to support new product introductions, technology transfers, continually monitor, troubleshoot and improve drug product operations conducted across the network on behalf of Alkermes. This role ensures robust, compliant, and efficient processes for drug...

Overview:We are currently seeking an Associate Director to join Technical Operations as process expert to support new product introductions, technology transfers, continually monitor, troubleshoot and improve drug product operations conducted across the network on behalf of Alkermes. This role ensures robust, compliant, and efficient processes for drug...

Associate Director, Gmp Quality Assurance (Drug Substance) At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera's mission to...

Job Description Overview: We are currently seeking an Associate Director to join Technical Operations as process expert to support new product introductions, technology transfers, continually monitor, troubleshoot and improve drug product operations conducted across the network on behalf of Alkermes. This role ensures robust, compliant, and efficient...