Senior PV Scientist: Signal Lead & Safety Reporting
Biogen, Inc.
Biogen, Inc. is seeking a Senior PV Scientist to lead safety activities across products and collaborate with cross-functional teams. You will own signal management, author aggregate safety reports, and respond to regulatory inquiries while ensuring compliance with global safety standards. You will mentor staff and coordinate with Global Safety Officers and Safety MDs on investigational programs and safety committee activities, fostering data-driven decision making and continuous improvement. #J-18808-Ljbffr Biogen, Inc.
- ...Associate Director, Pharmacovigilance Scientist to advance safety evaluation across clinical development... ...You will oversee SAE reviews, support signal management, and collaborate with cross... ...functional teams. The role requires extensive PV experience, strong regulatory...SeniorRemote job
$68 - $80 per hour
...on experiencePosition Summary The PV Aggregate Reports Scientist is part of the Safety Surveillance and Aggregate (SSA) Reports... ...Aggregate Report Management: Lead and conduct all aspects of... ...consistency in aggregate reporting, signal management, clinical trial safety...SuggestedLocal areaWorldwide$65 - $77 per hour
job summary: The PV Aggregate Reports Scientist is part of the Safety Surveillance and Aggregate (SSA) Reports team and... ...: Aggregate Report Management: Lead and conduct all aspects of... ...consistency in aggregate reporting, signal management, clinical trial safety...SuggestedHourly payContract workTemporary workWork experience placementLocal areaWorldwide$70 - $78 per hour
Pride Health is supporting a leading biotechnology organization with a hybrid contract opening for a PV Aggregate Reports Scientist within the Safety Surveillance and Aggregate (SSA) Reports... ...Quality, and external vendors. Support signal management, clinical trial safety...SuggestedContract workLocal area- ...(IRI) in Cambridge, MA is seeking a PV Aggregate Reports Scientist for a hybrid role (2-3 days in the office... ...W2 pay between $70 and $80. You will lead and author PSURs, DSURs, PADERs and... ...reporting, collaborate with Safety, Clinical Development, Medical Affairs...SeniorRemote jobHourly payContract workWork at officeLocal areaWorldwide
- Regeneron seeks a Senior Toxicologist to lead nonclinical development programs with guidance from a supervisor... ...design, conduct, analyze, and report regulatory toxicology and exploratory... ...oversight at CROs, and staying current with safety science to support IND/NDA #J-18808-...Senior
- ...Pharmaceuticals, Inc (USA) is seeking a Senior Toxicologist to lead nonclinical development programs with... ...of GLP regulations and FDA/ICH safety guidelines, with primary responsibility... ...designing, conducting, interpreting, and reporting regulatory toxicology studies and...Senior
- ...seeks an Associate Director, Pharmacovigilance Scientist to lead safety evaluation across clinical development and... ...include SAE review, safety analyses, signal management, regulatory documentation, and collaboration with PV vendors. #J-18808-Ljbffr Scorpion TherapeuticsSenior
- ...Pharmacovigilance Aggregate Reports Scientist Location: Cambridge, MA... ...Job Description: Lead and manage global aggregate safety reports, including PSURs,... ...compliant delivery. Serve as a PV subject matter expert on... ...safety regulations, signal management, and aggregate...Local area
$90k - $105k
...,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin... .... Job Description This scientist has a proven track record of cellular and... ...results in small group meetings and/or in reports Sample preparation of limited tissue...SeniorFull timeContract workWork at officeMonday to Friday$10k
About This Role:As a Senior Pharmacovigilance (PV) Scientist, you will play a pivotal role as a product lead within the Safety team, overseeing and spearheading critical... ...encompass managing the safety signal process, authoring aggregate reports like PSURs and DSURs, and...SeniorFull timeTemporary workLocal area- ...Description Job Description PV Scientist, Contractor, Safety Risk Management 6 Months... ...closely with the safety lead physician to analyze... ...potential safety issues, including signal detection, signal... ...not limited to, preparing reports, minutes and meeting documents...Permanent employmentContract workFor contractorsRemote work
- ...a Pharmacovigilance Aggregate Reports Scientist to lead the preparation of PSURs, DSURs, PADERs, and local safety reports for global submissions. The role requires acting as a PV subject matter expert on global safety regulations, signal management, and aggregate reporting...Local area
$172k - $237k
...Associate Director for the Safety Surveillance and Aggregate Reports group, you will play a... ...You’ll Do Serve as the lead PV Scientist for a specific product... ...scientific oversight. Oversee signal detection and management... ..., PV Scientists, and Senior PV Scientists....Temporary workWork at officeLocal area$119.7k - $222.3k
...motivated PK Sciences representative to lead the development and use of... ...components of study protocols, reports, project summaries and... ...to be considered for Principal Scientist II. 4+ years of experience to be considered for Senior Principal Scientist.Extensive and...SeniorFull time- As a Senior Scientist Immunology overseeing the design and execution of in vitro and in vivo mechanistic, proof-of-concept and safety studies, provide scientific and technical expertise in immune... ...filing with authoring of technical reports. This pivotal role offers a...Senior
- Pride Health is seeking a PV Aggregate Reports Scientist for a hybrid contract in Cambridge, MA. The role focuses on leading the preparation of PSURs, DSURs, PADERs, and other aggregate safety reports within the SSA team. The candidate should have at least 5 years of Pharmacovigilance...Contract work
- ...Job Description Job Description Scientist/Senior Scientist, Biology Lead – Kidney Experience About the Role We are seeking a highly motivated... ...partners · Contribute to patents, publications, study reports, and data presentations Required Qualifications...Senior
$159.75k - $255.6k
...explorers, pursuing society’s most critical safety and justice issues with our ecosystem of... ...skilled and innovative Machine Learning Scientists to join our AI team, focusing on AI... ...procedures. Axon employees are empowered to report safety concerns as they arise and...SeniorWork experience placementWork at officeRemote work- ...candidates, address stability and PK questions, and support in vivo biodistribution studies. Leadership within radiopharmacology, collaboration with cross-functional teams, and documentation for reports are key parts of the role. #J-18808-Ljbffr Mariana Oncology, Inc.Senior
- Regeneron is seeking a Senior Toxicologist to lead nonclinical development programs with regulatory oversight and cross‑functional collaboration... ...deep GLP and regulatory expertise to design, conduct, and report studies in rodent and non‑rodent models while aligning with...Senior
- Sanofi US Services in the United States is seeking a senior toxicology specialist to oversee the nonclinical safety program for R&D drug candidates. You will design safety studies, author regulatory documents, and collaborate with global teams and external partners to...Senior
$74.98 - $81.5 per hour
R&D Partners is looking for a Pharmacovigilance Scientist in Cambridge, MA, to analyze and manage safety issues. Responsibilities include collaborating with safety physicians and preparing safety reports. Requirements include a relevant degree, 3-5 years in drug safety,...- Novartis is seeking a Preclinical Safety Profiling Laboratory Associate in Cambridge, MA to join the PCS team. The role supports in-vitro... ...evaluation, and ensuring compliant data generation and reporting for small molecule programs #J-18808-Ljbffr Healthcare Businesswomen...Senior
- ...is seeking a highly motivated Senior Scientist in Toxicology to help drive the pre‑clinical safety strategy for the successful development... ...all stages of development. Reporting to the Head of Preclinical... ...will serve as Study Director, leading toxicology study operations...Senior
$139k - $170k
...Job Description Job Description About the Team The Maritime Domain Applications (MDA) Group is seeking a Radar Signal Processing Engineer to develop advanced sensing concepts utilizing adaptive radar signal processing, resource management, and advanced radar...SeniorFull timeLocal areaRemote workNight shift- ...future. The Opportunity Lead diagnostic R&D programs... ..., manage, analyse, and report on both internal and... ...quality, regulatory, and safety standards, and... ...train, and manage junior scientists and technical staff, fostering... ...innovation. As a Senior Scientist, you'll play...SeniorFull time
- CRISPR Therapeutics, Inc. in Boston, MA is hiring a Senior Specialist, Drug Safety to support ICSR processing and ensure high-quality safety cases. The role reports to Head of PV Ops and requires independent, detail-oriented work in a fast-paced Biotechnology environment...Senior
$187k - $281k
The Director, Safety Scientist serves as a key leader within... ...the portfolio through:Leading the scientific evaluation... ...) and Periodic Safety Reports (PSRs))Responsible for... ...and adherence to PV regulations for the assigned... .../tracking of all signal analysis resultsLeading...Full timeTemporary workLocal area$121k - $173k
...two centuries ago, FM is a leading mutual insurance company whose... .... FM is seeking a Senior Research Scientist to advance scientific understanding... ...in the field of battery safety. The ultimate goal is to... ..., planning, execution, reporting, and engineering application...SeniorFull timeFlexible hours
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