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.
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.
NewSr. Principal Scientist, Nonclinical Drug Safety Merck & Co IncSr. Principal Scientist, Nonclinical Drug SafetyBoston, MA$190,800–$300,300 / yearStrategically influence nonclinical drug safety considerations for Immunology programs by providing drug development mentorship and partnering with Compound Leaders on time-critical matters, including nonclinical program design and toxicology study design, weight-of-evidence risk assessments, science-based waiver strategies, and integrated safety development plans that support clinical trials, global registration, and timely resolution of nonclinical development issues. Provide scientific and strategic oversight for Immunology candidates through close collaboration with Program Coordinators, Discovery Preclinical Leaders, Compound Leaders, and scientists across NDS and/or Preclinical Development, while ensuring strong partnership with key Research and Development Division functions, including Discovery, chemistry, regulatory affairs, translational medicine, clinical development, and CMC.
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.
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 .
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.
Remote Pharmacovigilance / Drug Safety Pharmacist Pharmacy CareersRemote Pharmacovigilance / Drug Safety PharmacistBoston, MassachusettsRemoteRemote Pharmacovigilance Pharmacist – Drug Safety From Home | No Prior Pharma Experience Required Contribute to global patient safety by collecting, evaluating, and documenting adverse events — entirely from home. This role is open to pharmacists from hospital, ambulatory, community, or managed care backgrounds who have strong attention to detail and want to enter the pharmaceutical industry.
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.
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.
Senior 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.
Senior Specialist, Drug Safety CRISPR TherapeuticsSenior Specialist, Drug SafetySouth Boston, MassachusettsThe Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. The Company continues to expand its leadership in gene editing through the development of SyNTase editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction.
Senior Specialist, Drug Safety CRISPR Therapeutics AGSenior Specialist, Drug SafetySouth Boston, MA$105,000–$115,000 / yearThe Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY (exagamglogene autotemcel [exa-cel]), the world's first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. The Company continues to expand its leadership in gene editing through the development of SyNTase editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction.