Drug Safety Manager

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...

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...

Drug Safety & Pharmacovigilance Systems and Analytics LeadThe Global Safety System Analyst role is critical for supporting, analyzing, and optimizing pharmacovigilance and drug safety systems. The candidate will leverage Oracle SQL, Snowflake, Python, Tableau, and Spotfire expertise to ensure robust data management, analysis, visualization, and reporting....

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...

Job DescriptionWe are seeking an Associate Director, PV Systems to manage and enhance its global Argus Safety platform and PV reporting systems. This role will lead end-to-end safety systems activities including configuration, validation, E2B reporting, system integrations, and vendor collaboration. The position partners closely with PV Operations,...

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...

Site Name: USA - Massachusetts - Waltham, Belgium-Wavre, Cambridge MA, GSK HQ, Stevenage, Upper ProvidencePosted Date: Oct Job PurposeProvides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting. Ensures scientifically sound review and interpretation of...

Company Overview:Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and...

Company Overview:Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and...

Company Overview:Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and...