PV Scientist: Safety Signals & Regulatory Analytics
kozmetickesluzby.vecnakraska.sk - Jobboard
AVEO is seeking a PV Scientist in Boston, Massachusetts to support clinical safety through safety surveillance and regulatory reporting. This role involves developing signal management tools and collaborating with cross-functional teams to ensure compliance with pharmacovigilance regulations. The ideal candidate will have an advanced degree in a life sciences field and significant experience in safety analysis and signal detection. This position is part-time, requiring on-site attendance three days a week. #J-18808-Ljbffr kozmetickesluzby.vecnakraska.sk - Jobboard
$172k - $237k
...Associate Director for the Safety Surveillance and... ...Do Serve as the lead PV Scientist for a specific product... ...scientific oversight.Oversee signal detection and... ...Clinical Operations, and Regulatory colleagues.Respond to... ...determined through an analytical approach utilizing a combination...RegulatoryFull timeTemporary workWork at officeLocal area- ...Responsibilities *Works closely with the safety lead physician to analyze... ...safety issues, including signal detection, signal evaluation... ...to apply knowledge and analytical skills to problems in specific... ...LATAM, APAC) Pharmacovigilance regulatory requirements Understanding Signaling...Regulatory
$187k - $281k
The Director, Safety Scientist serves as a key leader within... ...effectively across clinical, regulatory, and other functions... ...and adherence to PV regulations for the assigned... .../tracking of all signal analysis resultsLeading... ...matrixStrong analytical, problem solving, and...RegulatoryFull timeTemporary workLocal area$126k - $190k
...within Global Patient Safety (GPS) to actively evaluate... ...within the global regulatory framework. You will be... ...for: Managing safety scientist activities across multiple... ...teams Responsible for Signal Review Meeting and... ...enhancement for safety analytics and reporting, such as...RegulatoryTemporary work$117k - $157k
...therapies that transform patients’ lives. We are seeking a Scientist II to join our Analytical Development team as a Liquid Chromatography (LC)... ...validation, transfer, and lifecycle management aligned with regulatory expectations. Participate in mentoring and knowledge-...RegulatoryFull timeTemporary workLocal area$117k - $158.2k
Overview:The Scientist, Analytical Sciences will be a member of the Stability team responsible for stability support of siRNA drug substances... ...be a significant contributor of data to CMC sections of regulatory filings. This position is onsite and will be primarily located...RegulatoryFull timeContract workTemporary workLocal areaFlexible hours$117k - $158.2k
Overview: The Scientist, Analytical Sciences will be a key team member of the Impurity Characterization team contributing to development and... ...efficiency by leveraging automation.Author development reports and regulatory filing documents and manage analytical activities...RegulatoryFull timeContract workTemporary workLocal areaFlexible hours$114.1k - $211.9k
...SummaryCambridge MAInternal: Principal Scientist I or IILI#-HybridThe Preclinical Safety (PCS) department within the... ...commercialization, with state-of-the-art regulatory compliance. As a Preclinical... ...to business users. Presents analytical content concisely and effectively...RegulatoryFull timeLocal area$187k - $281k
...The Director, Safety Scientist serves as a key leader within... ...across clinical, regulatory, and other functions... ...compliance and adherence to PV regulations for the assigned... .../tracking of all signal analysis results... ...functional matrix Strong analytical, problem solving, and...RegulatoryTemporary workLocal area- Aurion Biotech, Inc. in Cambridge, MA is seeking a Senior Scientist, Analytical Science & Technology to lead method transfers and validations... ...author and review protocols, evaluate data, and ensure regulatory compliance for QC testing of cell therapy products. The role...RegulatoryRemote job
$203.71k - $305.56k
...Clinical Development Scientist Location: Boston, MA or... ...execution—transforming signals into actions and... ...value trials, spotlight safety and efficacy trends early... ...participants and timelines. Data Analytics for Quality: Use... ...program strategy and regulatory needs. External...RegulatoryHourly payTemporary workWork at officeFlexible hours3 days per week- CRISPR Therapeutics is seeking a Senior Scientist in Analytical Development to lead development, qualification and technology transfer of cell... ...assay lifecycle, mentor scientists, ensure adherence to regulatory guidelines, and contribute to submissions while refining analytical...Regulatory
- ...Cambridge, MA team seeks a Process Development Senior Scientist in Attribute Sciences to advance analytical methods monitoring CQAs and support process... ...develop automation-enabled workflows, and contribute to regulatory submissions. A PhD or equivalent with deep analytical...Regulatory
- CRISPR Therapeutics, Inc. in Boston, MA, seeks a Senior Scientist in Analytical Development to drive development, implementation, and qualification... ...to collaborators. This role will author sections of regulatory briefing packages related to the technical function. The...Regulatory
- Kernal Biologics, Inc. in Boston, MA is seeking a Principal Scientist, Analytical Development to lead the design, development, and execution... ...ideal candidate brings deep expertise in analytical sciences, regulatory submissions, and fit-for-purpose method validation to...Regulatory
- Kailera Therapeutics is seeking a Scientist I for Analytical Development and Quality Control in Waltham, MA. This role involves analyzing stability and release data, ensuring compliance with regulatory standards, and contributing to data integrity in analytical systems....Regulatory
- Aurion Biotech, Inc. is seeking a Senior Scientist for Analytical Development in Cambridge, MA, to execute assays for cell therapy products.... ...with various teams, and authoring technical documents for regulatory submissions. Candidates should have a PhD or MS in related...Regulatory
- Aurion Biotech in Cambridge, MA is seeking a Senior Scientist, Analytical Science & Technology to lead method transfers and validations at external... ...robust assays, maintaining QC readiness, and supporting regulatory-ready documentation while collaborating with internal and...Regulatory
- Kernal Biologics, Inc. is seeking a Principal Scientist, Analytical Development for its Boston hub. You will lead design, development, and execution... ...candidates bring deep expertise in analytical sciences, regulatory submissions, and fit-for-purpose method development and...Regulatory
- Research Scientist, Cell and Gene Therapy Analytical (Contract) This Research Scientist position will be part of the Analytical Science and Technology... ...protocols, and technical reports. Prepare and review regulatory filings and responses. Knowledge and Skills: Hands-on...RegulatoryContract work
- Senior Scientist, CMC Analytical Development Join to apply for the Senior Scientist, CMC Analytical... ...radiochemistry, with a focus on ensuring the safety, efficacy, and compliance of... ...radiopharmaceuticals in accordance with regulatory guidelines. Reporting Line Vice...RegulatoryFull time
- ...process changes. Develop and transfer analytical methods used to characterize and monitor... ...transfer packages, specifications, and regulatory support documents. Collaborate with cross... ...and external partners. Mentor junior scientists and contribute to the continuous improvement...RegulatoryContract work
$155k - $170k
Senior Scientist, Analytical Development Location: Cambridge, MA Salary Range: $155,000 to $170,000 About the Position Aurion Biotech is seeking... ...test method SOP and other technical documents to support regulatory submissions and other groups. Track progress toward...RegulatoryWork at office$140k - $155k
Description JOB TITLE: Scientist II, Analytical Development LOCATION: Cambridge, MA SALARY RANGE: $140,000 to $155,000 ABOUT THE POSITION Aurion... ...test method SOP and other technical documents to support regulatory submissions and other groups. Track progress toward...RegulatoryWork at officeDay shift- ...California. Job Summary Reporting to the Director of Analytical Development, the Senior Scientist will be responsible for development, implementation,... ...outside CRISPR Therapeutics, and author sections of regulatory briefing packages or submissions related to technical...RegulatoryContract work
$140k - $155k
Description JOB TITLE: Senior Scientist, Analytical Science & Technology LOCATION: Cambridge, MA (hybrid-remote) REPORTS TO: Senior Manager... ...SOPs, and QC analytical data to cGMPs, pharmacopeial, and regulatory requirements Provide technical support for deviations,...RegulatoryContract workWork experience placementRemote workDay shift$71.25k - $187k
...seeking an exceptional Senior Principal Scientist to join our growing team. In this role,... ..., Discovery, and CMC groups to drive analytical characterization of circular RNA and lipid... ..., and SOPs to ensure alignment with regulatory expectations. Generate high‑quality data...RegulatoryFull timeH1bVisa sponsorshipWork visaFlexible hours$35 - $43 per hour
...Manufacturing Practices (GMP) Safety Standards, Laboratory Setting Job Description Scientist - RNA Sequencing / ddPCR Position... ..., optimize, and interpret analytical method development experiments... ...reports, study documentation, and regulatory support documents. Collaborate...RegulatoryHourly payFull timeContract workTemporary workWork at officeRelocationRelocation packageMonday to FridayShift workDay shift$154.4k - $242.55k
...DescriptionJoin Takeda as a The Senior/Principal Scientist, Analytical Cell Line Engineering and Bioessay... ...contribute to technical standards, regulatory-ready documentation, and capability... ..., including reporter gene assays, signaling pathway assays, proliferation or...RegulatoryMinimum wageTemporary workLocal areaShift work- ...product quality and yield. Analysis: Conduct analytical testing to confirm the quality and... ...accordance with company policies and applicable regulatory or quality standards. Laboratory... ...of workspaces, and adherence to safety and cleanliness requirements. Collaboration...Regulatory
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