NewProject Manager - FSP Team - Patient Safety Focused Thermo Fisher ScientificProject Manager - FSP Team - Patient Safety FocusedCambridge, MASee Thermo Fisher Scientific Terms & Conditions at https://www.thermofisher.com/us/en/home/global/terms-of-use.html and Privacy Policy at https://www.thermofisher.com/us/en/home/global/privacy-policy.html and SonicJobs Privacy Policy at https://www.sonicjobs.com/us/privacy-policy and Terms of Use at https://www.sonicjobs.com/us/terms-conditions. Within our Functional Service Provider (FSP) organization, the GPS Functional Project Manager, Process & Operations plays a critical role in supporting the successful delivery of Global Patient Safety (GPS) services by driving operational excellence, leading strategic initiatives, and continuously improving business processes.
Director/Senior Director, Pharmacovigilance and Drug Safety (Safety Scientist) Xenon PharmaceuticalsDirector/Senior Director, Pharmacovigilance and Drug Safety (Safety Scientist)Needham, MassachusettsThe successful candidate will author safety documents, reviews safety sections of other documents, for Xenon products throughout the product lifecycle from First-in-Human (FIH) to post-marketing, performs QC, and, when necessary, assists in responding to information requests from Health Authorities for Xenon products, participate in cross-functional Safety Risk Management Team (SRMT) meetings and collaborate with colleagues in Clinical Development, Trial Operations, Clinical Pharmacology, Biostatistics & Programming, Regulatory, Medical Affairs, non-clinical safety lead, QA and Legal departments. * Support and review safety-related documents for Xenon products throughout product lifecycle from FIH to post-marketing such as Safety Assessment Reports, product labeling, risk management/risk mitigation-related documents, and responses to ad-hoc information requests by Health Authorities and internal stakeholders.
VP of Drug Safety/Pharmacovigilance Compass Therapeutics IncVP of Drug Safety/PharmacovigilanceBoston, MA$325,000–$450,000 / yearProvide executive oversight and review of safety-related regulatory submissions, cross functionally collaborating with Clinical, Medical, Quality, and Regulatory, including DSURs, DCSI, Risk Management Plans, Investigator Brochures, Clinical Study Report, Informed Consent Forms (ICFs), protocols, reports, other required safety documentation in accordance with legal requirements, respective SOPs and Health Authority. Ensure patient safety by monitoring patient safety profiles to identify and mitigate potential risks associated with Compass drugs; recommend updates to Development Core Safety Information (DCSI)/Reference Safety Information, communicate risks to applicable stakeholders.
Director, Drug Safety & Pharmacovigilance Scientist Dyne TherapeuticsDirector, Drug Safety & Pharmacovigilance ScientistWaltham, MA$220,000–$240,000 / yearThe Director collaborates across Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, Quality, and external partners to support proactive safety oversight and informed program decision-making. Cross-Functional Leadership & Safety Governance Partner with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, Quality, and external vendors to integrate safety considerations into study conduct and program strategy.
Sr. Medical Director, Drug Safety & Pharmacovigilance Scholar RockSr. Medical Director, Drug Safety & PharmacovigilanceCambridge, MABy harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Responsible for oversight and conduct of Product Safety Committee (PSC) meeting(s) to evaluate risk-benefit for the compounds with support from cross-functional teams.
Director, Drug Safety & Pharmacovigilance (Inflammation & Oncology) Monte Rosa Therapeutics IncDirector, Drug Safety & Pharmacovigilance (Inflammation & Oncology)Boston, MAThis role is responsible for establishing and executing global safety strategy across early- and mid-stage clinical programs, with particular focus on immune-mediated toxicities, oncology risk management, and complex benefit-risk assessment. The Director of Drug Safety & Pharmacovigilance provides strategic and hands-on leadership for pharmacovigilance activities supporting a clinical-stage biotech pipeline in inflammatory and oncology diseases.
Vice President, Global Head of Drug Safety (DS) & Pharmacovigilance (PV) Hemab ApSVice President, Global Head of Drug Safety (DS) & Pharmacovigilance (PV)Boston, MADevelop processes for and provide safety medical oversight of safety surveillance and benefit risk assessments, including medical review of ICSRs, signal management activities, safety analyses, benefit risk profile development and monitoring, and risk mitigation strategies. This role requires a hands-on leader with robust medical and operational expertise, a strong understanding of global regulatory requirements, and the ability to design and oversee a robust fit-for-purpose safety system that scales with company growth to support excellence in Drug Safety & Pharmacovigilance as a critical part of our mission.
VP of Drug Safety/Pharmacovigilance Compass TherapeuticsVP of Drug Safety/PharmacovigilanceBoston, MassachusettsProvide executive oversight and review of safety-related regulatory submissions, cross functionally collaborating with Clinical, Medical, Quality, and Regulatory, including DSURs, DCSI, Risk Management Plans, Investigator Brochures, Clinical Study Report, Informed Consent Forms (ICFs), protocols, reports, other required safety documentation in accordance with legal requirements, respective SOPs and Health Authority. Ensure patient safety by monitoring patient safety profiles to identify and mitigate potential risks associated with Compass drugs; recommend updates to Development Core Safety Information (DCSI)/Reference Safety Information, communicate risks to applicable stakeholders.
Senior Medical Director, Global Drug Safety Replimune Group, Inc.Senior Medical Director, Global Drug SafetyWoburn, MA$307,000–$397,000 / yearThis position provides pharmacovigilance expertise to and lead collaborations with external partners as well as with other functions across Replimune, including Regulatory Affairs, Clinical Development, Clinical Operations, Medical Affairs, or the Commercial to ensure that drug safety communications are accurate, complete and consistent. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response.
Director, Drug Safety & Pharmacovigilance Scientist Dyne Therapeutics IncDirector, Drug Safety & Pharmacovigilance ScientistWaltham, MA$220,000–$240,000 / yearRole Summary: The Director, Drug Safety & Pharmacovigilance Scientist provides strategic and scientific leadership for safety surveillance, signal detection, benefit-risk evaluation, and risk management activities across Dyne's development programs. The Director collaborates across Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, Quality, and external partners to support proactive safety oversight and informed program decision-making.
PV Drug Safety Consultant IntelliPro Group Inc.PV Drug Safety ConsultantCambridge, MAon W2 Job Description: The PV Aggregate Reports Scientist is part of the Safety Surveillance and Aggregate (SSA) Reports team and is responsible for managing the processes for all aggregate reports (PSURs, DSURs, PADERs, and local reports). Schedule & Regulatory Oversight: Support the Aggregate Reports Master Schedule (production, updates, stakeholder reviews), conduct worldwide legislation reviews for aggregate reporting, and provide impact assessments.
Senior Medical Director, Global Drug Safety ReplimuneSenior Medical Director, Global Drug SafetyWoburn, Massachusetts$307,000–$397,000 / yearThis position provides pharmacovigilance expertise to and lead collaborations with external partners as well as with other functions across Replimune, including Regulatory Affairs, Clinical Development, Clinical Operations, Medical Affairs, or the Commercial to ensure that drug safety communications are accurate, complete and consistent. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response.
Drug Safety Scientist Integrated Resources, IncDrug Safety ScientistRockland, MassachusettsFull timeParticipate in the set-up and approval of local clinical trials by developing drug safety manuals and SAE reconciliation plans, and conducting CRF reviews, and collaborating with US Drug Safety Medicine and GDS for the development and execution of Clinical Development plan as needed. To utilize medical knowledge and operational expertise to ensure patient safety by performing medical assessment of adverse events, assembling up-front safety information, collecting quality follow-up and ensuring medical information is included in cases for investigational and marketed products.
Director, Drug Safety & Pharmacovigilance (Inflammation & Oncology) Monte Rosa Therapeutics, IncDirector, Drug Safety & Pharmacovigilance (Inflammation & Oncology)Boston, MassachusettsFull timeThis role is responsible for establishing and executing global safety strategy across early‑ and mid‑stage clinical programs, with particular focus on immune‑mediated toxicities, oncology risk management, and complex benefit–risk assessment. Overview: The Director of Drug Safety & Pharmacovigilance provides strategic and hands‑on leadership for pharmacovigilance activities supporting a clinical‑stage biotech pipeline in inflammatory and oncology diseases .
NewSenior Medical Director, Global Drug Safety Replimune Group IncSenior Medical Director, Global Drug SafetyWoburn, MA$307,000–$397,000 / yearThis position provides pharmacovigilance expertise to and lead collaborations with external partners as well as with other functions across Replimune, including Regulatory Affairs, Clinical Development, Clinical Operations, Medical Affairs, or the Commercial to ensure that drug safety communications are accurate, complete and consistent. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response.
US_Drug Safety Consultant II TalentBurst, Inc.US_Drug Safety Consultant IICambridge, MA$79.61 / hourPosition Summary The PV Aggregate Reports Scientist is part of the Safety Surveillance and Aggregate (SSA) Reports team and is responsible for managing the processes for all aggregate reports (PSURs, DSURs, PADERs, and local reports). Schedule & Regulatory Oversight: Support the Aggregate Reports Master Schedule (production, updates, stakeholder reviews), conduct worldwide legislation reviews for aggregate reporting, and provide impact assessments.
US_Drug Safety Consultant II - Contract TalentBurst, Inc.US_Drug Safety Consultant II - ContractCambridge, MA$79.61 / hourPosition Summary The PV Aggregate Reports Scientist is part of the Safety Surveillance and Aggregate (SSA) Reports team and is responsible for managing the processes for all aggregate reports (PSURs, DSURs, PADERs, and local reports). Schedule & Regulatory Oversight: Support the Aggregate Reports Master Schedule (production, updates, stakeholder reviews), conduct worldwide legislation reviews for aggregate reporting, and provide impact assessments.
Medical Director, Global Drug Safety Replimune Group, Inc.Medical Director, Global Drug SafetyWoburn, MA$257,500–$333,500 / yearThe RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. Replimune's mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient's lives depend on it.
US_Drug Safety Consultant II MindlanceUS_Drug Safety Consultant IICamrbidge, MAPosition Summary The PV Aggregate Reports Scientist is part of the Safety Surveillance and Aggregate (SSA) Reports team and is responsible for managing the processes for all aggregate reports (PSURs, DSURs, PADERs, and local reports). Schedule & Regulatory Oversight: Support the Aggregate Reports Master Schedule (production, updates, stakeholder reviews), conduct worldwide legislation reviews for aggregate reporting, and provide impact assessments.
Medical Director, Global Drug Safety ReplimuneMedical Director, Global Drug SafetyWoburn, Massachusetts$257,500–$333,500 / yearThe RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it.