121 Results for

Drug Safety Jobs in Chelsea, MA

Jobs

Needham, Massachusetts

The 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. Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need.

19 days ago

Waltham, MA

$246,400–$308,000 / year

Zenas' earlier stage programs include ZB021, a clinical-stage, potentially best-in-class, oral, IL-17AA/AF inhibitor; ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor; and ZB014, a preclinical half-life extended anti-CD-19 and FcRIIb monoclonal antibody. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases.

27 days ago

Cambridge, MA

$210,000–$235,000 / year

Contribute to the generation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports, and provide medical input in review of new or existing safety documents to ensure compliance with relevant regulatory requirements, such as protocols, safety summaries and regulatory reports. The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.

30+ days ago

Boston, MA

This 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.

30+ days ago

South Boston, MA

$105,000–$115,000 / year

The 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.

30+ days ago

Boston, Massachusetts

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. This 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.

30+ days ago

South Boston, MA

$140,000–$155,000 / year

30+ days ago

Waltham, MA

In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts' Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine. Ensure all required safety forms, templates, and documentation are in place and aligned across systems and vendors, including but not limited to SAE and pregnancy reporting forms, narrative templates, IND safety report cover letters, fax cover sheets, and study‑specific safety documentation.

30+ days ago

Cambridge, MA

$106,000–$138,000 / year

p>Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

Ensures all AE case processing, in both the Post-Marketing and Clinical Trial settings, is conducted in compliance with regulatory requirements, corporate and departmental procedure and data handling conventions by maintaining and executing oversight plans for vendors (CROs) with case processing responsibilities.

30+ days ago

Cambridge, MA

$194,000–$267,000 / year

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

The Associate Medical Director, Global Safety Physician will be responsible for global pharmacovigilance for investigational and/or marketed products, including:

• review and analysis of safety data • design of clinical trials • identification and investigation of safety signals • management of benefit-risk profile for assigned compounds and products.

30+ days ago

South Boston, Massachusetts

The 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.

30+ days ago

South Boston, Massachusetts

30+ days ago

Cambridge, MA

$170,000–$195,000 / year

Responsibilities: Contribute to the generation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports, and provide medical input in review of new or existing safety documents to ensure compliance with relevant regulatory requirements, such as protocols, safety summaries and regulatory reports. The Role: Reporting to the Head of PV Science, the Associate Director, Drug Safety and Pharmacovigilance Scientist is responsible for assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports.

30+ days ago

Cambridge, MA

$232,500–$335,833.33 / year

The GPH will collaborate with the Principal Clinical Lead (PCL) and Global Project Manager (GPM) to lead the cross-functional GPT (which includes translational, regulatory, drug manufacturing, safety, medical and commercial compound leads), to ensure correct planning and implementation of end-to-end compound strategy. Key Responsibilities: The Global Project Head (GPH) drives worldwide clinical development and life cycle management for a late-stage Sanofi Antibody Drug Conjugate (ADC) compound within Solid Tumor Oncology.

30+ days ago

Boston, MA

p>This individual will serve as a key scientific and operational leader inside the company, partnering closely with computational scientists, experimental scientists (own lab), platform teams, translational biology, external collaborators, and executive leadership to prioritize programs, guide strategic decisions, and accelerate pipeline execution.

This is a critical executive leadership role for a hands-on scientific leader who has spent significant time navigating the realities of drug discovery and development - someone who understands not only what can work scientifically, but what actually translates into successful therapeutic programs.

27 days ago

$167,000–$205,000 / year

p>POSITION OVERVIEW:

Reporting to Executive Director, Biologics Drug Product; the Principal Scientist / Associate Director in Biologics Drug Product Development will be responsible for providing leadership for drug product technical elements of assets within the biologics pipeline programs, focusing on antibodies and/or proteins.

10-15 years in the pharmaceutical / biopharmaceutical industry with a minimum of 4-6 years of hands-on experience with early and/or late-stage drug product development programs, such as formulation, process, and/or device development and technology transfer.

30+ days ago

Billerica, MA

$86,500–$96,500 / year

p>Process Design & Operational Enablement: • Lead design, mapping, and optimization of manufacturing processes in consultation with global process owners • Work with Digital/IT to translate operational requirements into SAP S/4HANA configuration • Validate master data from an operations and GMP perspective • Ensure GMP/GxP and data integrity compliance in daily manufacturing execution.

Work Conditions:

Office Controlled/manufacturing area Physical Requirements: • Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, talk and hear • Be able to multitask • Operate computer/office machines.

30+ days ago

Boston, Massachusetts

This is a critical executive leadership role for a hands-on scientific leader who has spent significant time navigating the realities of drug discovery and development — someone who understands not only what can work scientifically, but what actually translates into successful therapeutic programs.

29 days ago

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Leverage knowledge of R&D Products and Platforms (ex: Veeva, Medidata, IQVIA, etc.) to advise on strategic planning, functional data flow, product implementations (ex: configuration, deployment, migration, and GxP testing), R&D stakeholders & processes, and platform ecosystem management;

Advise on R&D business process enhancements based on experience/best practices, business knowledge, and gaps in current vs.

In lieu of an MBA or PhD, 5-8 years of relevant work experience may substitute;

Required: At least 2 years of direct product services/design/implementation/management experience with Veeva Vault Clinical or Veeva Vault Regulator product suites and data.

30+ days ago

Plainville, Massachusetts

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For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards.

7 days ago

Boston, MA

$23.34–$33.37 / hour

Familiarity with pharmacy practice settings, legal requirements and limitations, prescription information and calculations, drug identification and generic equivalents, drug manufacturing, packaging and labeling information, and proper drug handling and storage practices. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success.

30+ days ago

Cambridge, MA

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. You will support a diverse portfolio of biologics, including monoclonal antibodies (mAbs), BiTEs, bispecifics, biosimilars, and other novel protein‑based modalities, and play a key role in advancing late‑stage and commercial drug substance strategies across Amgen's manufacturing network.

30+ days ago

Cambridge, MA

p>In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
You will support a diverse portfolio of biologics, including monoclonal antibodies (mAbs), BiTEs, bispecifics, biosimilars, and other novel protein‑based modalities, and play a key role in advancing late‑stage and commercial drug substance strategies across Amgen's manufacturing network.

30+ days ago

Massachusetts

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
You will support a diverse portfolio of biologics, including monoclonal antibodies (mAbs), BiTEs, bispecifics, biosimilars, and other novel protein‑based modalities, and play a key role in advancing late‑stage and commercial drug substance strategies across Amgen’s manufacturing network.

19 days ago

Boston, Massachusetts

$55–$65 / hour

a> Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners.

By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex.

5 days ago

Bedford, MA

$78,300–$96,700 / year

For us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.

14 days ago

Cambridge, MA

$168,000–$220,500 / year

You will thrive in an environment where you can share expertise across functions and global UCB sites, engage with cutting-edge science and build collaborative networks to drive cross-functional success.

This role is well suited to an experienced toxicologist-ideally with exposure to gene and cell therapy or other novel modalities-who enjoys working at the interface of science, development strategy, and regulation.

30+ days ago

Lexington, MA

$150,000–$190,000 / year

p>Lead multiple projects as subject matter expert, function as project leader for projects comprising multiple experimental activities & coordination of activities to meet deadlines, communicate project updates & experimental results, provide expert-level guidance to experimental plans & data interpretation; may propose & lead external research efforts to support project goals; attend & present at scientific conferences as an NN-subject matter expert; deep understanding of subject matter & demonstrate creative thinking & solutions for addressing critical scientific questions; may supervise junior staff; author internal reports & external publications; recommend, present, & champion new targets or methodologies. Internal relationships include working closely with technical staff & other members of the scientific leadership team; regular collaborations with members of other research departments at Novo Nordisk; & frequent interaction with project managers & other colleagues across global R&D.

7 days ago

Boston, MA

$350,000–$380,000 / year

p>Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. The VP will drive an integrated, science-driven global safety strategy for the company's small molecule pipeline, working closely with internal stakeholders and teams, as well as global health authorities.

30+ days ago

Somerville, MA

This role is designed for a highly experienced safety leader who can operate with broad autonomy, influence senior cross-functional stakeholders, and drive an integrated, proactive, and scientifically rigorous approach to signal detection, aggregate safety assessment, benefit-risk evaluation, and safety governance across development programs. Oversee the preparation and strategic quality of core safety deliverables, including DSURs and other aggregate reports, Reference Safety Information, safety sections of Investigator Brochures, protocols, informed consent forms, clinical study reports, regulatory responses, and other key documents.

30+ days ago

Boston, MA

$280,895–$421,342 / year

Leads the safety physicians and scientists to support the safety strategy and input into the program design, monitoring, and data interpretation from pre-clinical and clinical studies, communication and post-marketing surveillance, epidemiology, pre-clinical and literature, epidemiology for each asset. Is accountable for project representation for Global Patient Safety at governance and other forums where safety is involved, eg DRC, eCRC, SARB, FSIRB, and DSMB/DMC, Medical Affairs Review Committees (MARC), product teams such CPT and GPT and Advisory Board meetings in partnership with GSH.

30+ days ago

Boston, Massachusetts

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Is accountable for project representation for Global Patient Safety at governance and other forums where safety is involved, eg DRC, eCRC, SARB, FSIRB, and DSMB/DMC, Medical Affairs Review Committees (MARC), product teams such CPT and GPT and Advisory Board meetings in partnership with GSH.

30+ days ago

Boston, MA

$249,827.20–$374,740.80 / year

p>We would prefer for you to have:

2-3 years safety and risk management experience in the pharmaceutical, biotech or CRO industry Rare, Ultra-Rare or Orphan Disease Area experience Strong verbal and written communication skills including making recommended courses of action to management Excellent, independent judgment based on knowledge and expertise Strong personal time-management and project-management skills Proficiency in Microsoft Word, PowerPoint and Excel. Evaluating aggregate safety data and providing contributions to core regulatory documents i.e. Periodic Safety Update Reports, Drug Safety Update Reports, Risk Management Plans, and other routine and non-routine safety and risk/benefit evaluations for internal or regulatory purposes as required.

30+ days ago

Cambridge, MA

$199,000–$343,275 / year

Required Skills: Preferred Skills: Clinical Operations, Clinical Research and Regulations, Clinical Trials, Collaborating, Data Governance, Data Management and Informatics, Developing Others, Drug Discovery Development, Global Market, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Market Research, Program Management, Research Ethics, Scientific Evaluation, Scientific Research, Stakeholder Management The anticipated base pay range for this position is : The anticipated base pay range for this position is: $199,000-$343,275 Additional Description for Pay Transparency: The anticipated base pay range for this position is: $199,000-$343,275 The Company maintains highly competitive, performance-based compensation programs. Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Clinical Development & Research - MD Job Category: People Leader All Job Posting Locations: Beerse, Antwerp, Belgium, Cambridge, Massachusetts, United States of America, San Diego, California, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America Job Description: Director, Clinical Translational Safety Lead (Within Translational Safety-TPPIT) In addition to the US based locations, this role can also be based in Belgium, which is linked to R-071725 Clinical Translational Safety Lead.

30+ days ago

Boston, Massachusetts

li>Evaluating aggregate safety data and providing contributions to core regulatory documents i.e. Periodic Safety Update Reports, Drug Safety Update Reports, Risk Management Plans, and other routine and non-routine safety and risk/benefit evaluations for internal or regulatory purposes as required.

Representing Alexion GPS at internal strategic and/or advisory/governance committees, other project/product team(s) or subteam(s) as a key cross functional member and subject matter expert, and/or act as an external technical resource at DSMB or Regulatory Authority meetings.

4 days ago

Boston, MA

$186,666–$251,068 / year

Follow this link for more details: Ionis Benefits: https://www.ionis.com/careers/working-at-ionis/#:~:text=our%20employee%20spotlight-,Benefits,-Employees%20are%20rewarded. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.

30+ days ago

Cambridge, Massachusetts

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We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. This role will have specific emphasis and accountability for products in Moderna’s emerging and/or established Systemic IV portfolio (spanning Autoimmune, Immuno-Oncology, and/or Rare Disease), with additional responsibilities to partner with Platform Science teams to support the safety evaluation and optimization of novel and existing technologies, as well as in other therapeutic areas as needed based on evolving business needs.

30+ days ago

Waltham, MA

In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts' Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine. Key success factors also include building high trust, accountability and demonstrating a sense of urgency in leading critical projects, showing the capability to work either independently or collaboratively in a matrixed environment, and to be able to effectively communicate with varied stakeholders.

14 days ago

Cambridge, MA

$114,100–$211,900 / year

Participate in cross-functional early safety screening & profiling collaborations with Novartis Biomedical Research partners to support the early derisking of compounds, drug targets, and therapeutic modalitiesDeliver clear and concise presentations for audiences with different expertiseIn collaboration with cross-functional partners, provide scientific and strategic input to support the early derisking of compounds, drug targets, and therapeutic modalitiesEnsure quality and compliance of data generation, analyses and resultant reportsEssential RequirementsDegree/Advanced Degree in Pharmacology, Toxicology or a Related Field5+ years of relevant experience in pharmacology / toxicologyUnderstands the basic concepts of hazard identification and risk assessment associated with drug ADME, off-target mitigation and cardiovascular safety.

Cambridge MAInternal: Principal Scientist I or IILI#-HybridThe Preclinical Safety (PCS) department within the Novartis Biomedical Research Translational Medicine Unit provides world class preclinical safety profiling and assessment for optimal drug discovery, development and commercialization, with state-of-the-art regulatory compliance.

12 days ago

Waltham, MA

The Senior Safety Scientist collaborates primarily with the Product Safety Lead/Safety Physician for assigned products, and also with cross-functional team members to ensure active safety surveillance of SAEs and other clinical trial safety data and lead/assist in the preparation of safety-related documents.

Cross-Functional Collaboration: Work closely with clinical operations, clinical development, regulatory affairs, and other departments, including the PV vendor, to ensure the safety of clinical trial participants.

8 days ago

Waltham, MA

The Safety Scientist collaborates primarily with the Product Safety Lead/Safety Physician for assigned products, and also with cross-functional team members to ensure active safety surveillance of SAEs and other clinical trial safety data and lead/assist in the preparation of safety-related documents.

8 days ago

Boston, Massachusetts

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Authoring safety sections, in collaboration with team members, on regulatory responses, IBs/CCDS, protocols, ICFs, Data Monitoring Committee reports and requests, and other documents, and provide the necessary quality control to ensure alignment with core safety position.

The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework.

15 days ago

Skills: Excellent leadership and line management skills Excellent knowledge of drug safety and the drug development process Excellent knowledge of and ability to interpret and apply global safety regulations Experience in data analysis, evaluation of safety data and the preparation of safety reports preferred Excellent team / project leadership and delegation skills Ability to train and mentor people Excellent presentation skills Excellent interpersonal skills Excellent time management skills Client focused approach to work Experience with Pharmacovigilance related computing systems Clinical Research or Pharmacovigilance knowledge /qualifications Computer proficiency, ability to work with web-based applications and familiarity with the Windows operating system and Microsoft Office apps Ability to comprehend various regulatory or client requests and be able to strategize a handling approach Flexible attitude with respect to work assignments and new learnings Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Willingness to work in a matrix environment and to value the importance of teamwork Knowledge and Experience: Minimum 13+ years of pharmaceutical and/or CRO experience including but not limited to areas of focus in clinical operations, sales and decentralized clinical trials/direct to patient studies 7-10 years of management experience, including direct project management or program oversight Requires BA/BS degree or equivalent combination of education and experience or equivalent related degree and/or experience, plus significant executive and/or senior management experience, preferably in worldwide clinical research, pharmaceutical, or biotechnology company A strong background in Safety Operations execution is desirable Minimum of thirteen (13) years of related experience, including seven to ten (7-10) years of progressive management experience, including direct project management or program oversight. You will lead operational level planning with significant business oversight, drive 'positive change' throughout Parexel through continuous process improvement programs, as well as make significant contributions to the leadership of the Business Unit (BU) and the development of the strategy and direction of the BU.

30+ days ago

Cambridge, MA

$178,500–$297,500 / year

li>

Review, preparation, contribution and/or approval of clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary of safety, summary of clinical safety, and labeling. But progress doesnt happen without people people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen.

30+ days ago

Boston, Massachusetts

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The Director, Safety Scientist plays a leadership role within Global Patient Safety organizing and mentoring safety scientists to actively evaluate, manage and strategize risk in collaboration with the GDS Medical Directors and cross-functional team members within the global regulatory framework.

Responsible for authoring safety section in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review, Data Monitoring Committees reports and requests, and other documents, and provide the necessary quality control to ensure alignment with core safety position.

15 days ago

Boston, MA

$230,000–$317,000 / year

Minimum 8 years of experience as pharmacovigilance physician with strong experience in handling ICSR processing for clinical trials and marketed drugs, signal detection , aggregate reports development and safety analyses from clinical trials.

The Medical Safety Physician will be responsible for the medical safety activities of all pharmacovigilance activities for the assigned products including medical review of all ICSR, aggregate reports related activities and support signal detection, risk management, and submission associated activities.

13 days ago

Lexington, MA

This includes (but is not limited to) providing thorough sponsor oversight of delegated safety responsibilities outsourced to safety vendor, leading operations in development of aggregate reports (e.g., DSUR, PAER), providing new hire AE/SI training, and planning Internal Safety Review Committee (SRC) and Safety Review Team (SRT) meetings.

Working knowledge of domestic and international regulatory safety reporting requirements for investigational and marketed products, including FDA/ICH guidance's related to pharmacovigilance (e.g., E2B) and Good Clinical Practices, as well as working knowledge of Code of Federal Regulations regarding drug safety.

30+ days ago

$286,560–$347,244 / year

li>

Oversee, prepare and/or review aggregate safety review documents (eg, Development Safety Update Reports [DSUR], Periodic Benefit-Risk Evaluation Reports [PBRER]) and safety sections of relevant clinical trial documents (eg, protocols, clinical study reports [CSR], investigator brochures [IB], informed consent forms [ICF]) and regulatory filings (eg, clinical trial applications [CTA], marketing authorization applications [MAA]).

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

30+ days ago

Cambridge, MA

li>Oversees quality content of the safety contributions to clinical and regulatory documents such as briefing book for regulatory authority meetings, investigator's brochure, clinical study report safety conclusion section, responses to regulatory authority inquiries, and other clinical/regulatory documents as needed. The MSP also ensures compliance with Good Clinical Practice (GCP) and regulatory reporting requirements, while contributing to essential safety documents such as Development Safety Update Reports (DSURs), updates to reference safety information, Investigator Brochures, and Clinical Trial Reports.

27 days ago

Boston, MA

$212,000–$333,190 / year

You will be embedded in the DMTA cycle from early hit assessment through IND-enabling studies, working alongside medicinal chemists, computational scientists, and biologists to flag liabilities early, design around them fast, and build the nonclinical dossier that gives programs the best possible chance in the clinic.

Own the nonclinical safety strategy across the AIRx portfolio, including small molecule and biologics projects, from early screening through IND-enabling studies; ensure every program has a clear, risk-proportionate toxicology plan aligned to its clinical hypothesis and regulatory pathway.

6 days ago

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Drug Safety Jobs in Chelsea, MA

Director/Senior Director, Pharmacovigilance and Drug Safety (Safety Scientist) Xenon Pharmaceuticals

Medical Director - Drug Safety & Pharmacovigilance Zenas BioPharma (USA) LLC

Associate Medical Director, Drug Safety and Pharmacovigilance PV Nuvalent Inc

Director, Drug Safety & Pharmacovigilance (Inflammation & Oncology) Monte Rosa Therapeutics Inc

Senior Specialist, Drug Safety CRISPR Therapeutics AG

Director, Drug Safety & Pharmacovigilance (Inflammation & Oncology) Monte Rosa Therapeutics, Inc

Senior Manager, Drug Safety CRISPR Therapeutics AG

Drug Safety Program Manager Alkermes Plc

Sr Associate II, Drug Safety Biogen Inc

Associate Medical Director, Global Drug Safety Biogen Inc

Senior Specialist, Drug Safety CRISPR Therapeutics

Senior Manager, Drug Safety CRISPR Therapeutics

Associate Director, Drug Safety and Pharmacovigilance Scientist Nuvalent Inc

Global Project Head, Solid Tumor Antibody Drug Conjugates (ADCs) Sanofi

VP/SVP of Drug Discovery Deep Origin Inc

Associate Director, Drug Product Disc Medicine Inc

Manufacturing Process Owner - Drug Product Formulation (SAP S/4 HANA Enablement) Sun Pharmaceutical Industries Ltd

VP/SVP of Drug Discovery Deep Origin

Strategy Insights & Planning Consultant - R&D Drug Development Veeva ZS Associates Inc

Drug Product MSAT Scientist II Thermo Fisher Scientific

Pharmacy Technician III - Investigational Drug Service Brigham and Women's Hospital

Director, Bioprocess / Process Development - Pivotal Drug Substance Amgen Inc

Senior Director, Bioprocess / Process Development - Pivotal Drug Substance Amgen Inc

Senior Director, Bioprocess / Process Development – Pivotal Drug Substance Amgen

Material Operations - Drug Product, Supply Chain Senior Specialist (Contract) 29251 Vertex Pharmaceuticals

Manufacturing Associate II, Drug Substance Upstream - Gene Therapy - Day Shift Pitman rotation Ultragenyx Pharmaceutical Inc

Non-Clinical Safety Lead - Cambridge, MA UCB SA

Senior Scientist II - Non-clinical Safety Novo Nordisk AS

Vice President, Pharmacovigilance & Safety Centessa Pharmaceuticals Plc

Director, Safety Science Generate Biomedicines Inc

Global Safety Program Lead/Sr Medical Director Alexion Pharmaceuticals Inc

Global Safety Program Lead/Sr Medical Director Alexion

Medical Director, Global Patient Safety Alexion Pharmaceuticals Inc

Director, Clinical Translational Safety Lead Johnson & Johnson

Medical Director, Global Patient Safety Alexion

Associate Director/Director, Patient Safety Operations Ionis Pharmaceuticals Inc

Senior Director, Nonclinical Safety Evaluation ModernaTX

Sr. Medical Director/Medical Director, Global Safety Officer Alkermes Plc

Preclinical Safety Profiling Expert, Principal Scientist Novartis AG

Senior Safety Scientist Viridian Therapeutics Inc

Safety Scientist Viridian Therapeutics Inc

Associate Director, Safety Scientist Alexion

Executive Director, Patient Safety Parexel International Corp

Global Safety Officer, I&I Sanofi

Director, Safety Scientist Alexion

Medical Safety Physician, Pharmacovigilance Verastem Inc

Manager, Global Medical Safety Kiniksa Pharmaceuticals International Plc

Director, Medical Safety Assessment Physician Bristol-Myers Squibb Co

Director Safety Physician BioNTech SE

AIRx, Sr. Director, Nonclinical Safety Lead Takeda Pharmaceutical Co Ltd

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