Senior PV Lead: Safety, Signals & Regulatory Submissions
$170k - $200kKyverna Therapeutics
Kyverna Therapeutics is seeking a Sr Manager/Associate Director of Safety and Pharmacovigilance to join their team in Emeryville, California. The role will involve oversight of both safety operations and pharmacovigilance activities for investigational and marketed products. Key responsibilities include management of vendor relationships, signal detection, and collaboration on regulatory submissions. The ideal candidate will have a strong background in pharmacovigilance practices and experience in neurology or autoimmune diseases. Compensation includes a salary range of $170K to $200K annually along with eligibility for bonuses and benefits. #J-18808-Ljbffr Kyverna Therapeutics
$170k - $200k
...Therapeutics is seeking a Sr Manager/Associate Director of Safety and Pharmacovigilance to join their team in... ...include management of vendor relationships, signal detection, and collaboration on regulatory submissions. The ideal candidate will have a strong background...SeniorRegulatory- ...eligible required Senior Medical Director, Patient Safety &... ...safety strategy, signal management, benefit... ...Responsibilities: • Lead safety strategy... ...Annual Reports, and regulatory safety documentation... ...regulatory submissions including INDs and... ...drive compliant PV operations and processes...SeniorRegulatory
$300k - $375k
...: The Senior Director, Drug Safety and Pharmacovigilance... ...Development Lead Physician(s) to facilitate signal detection monitoring... ...-safety related regulatory reports and... ...and provision of PV training as needed... ...Experience filing submissions for marketing authorization...SeniorRegulatoryRemote workFlexible hours- BridgeBio Pharma in California is seeking a Regulatory CMC professional to lead the regulatory strategy for IND, NDA, and MAA submissions. The role requires extensive experience in regulatory affairs within biotechnology and a strong ability to mentor team members. Responsibilities...SeniorRegulatoryRemote jobWork at office
$160k - $220k
...Senior Lead, Underwriting Denver, CO or San Francisco, CA or Madison... ...on complex or non-standard submissions that fall outside standard... ...appetite tightening, or pricing signals Contribute to reinsurance... ..., reinsurance meetings, and regulatory audits as the technical UW...SeniorRegulatoryShift work- ...seeking a Head of Drug Safety & Pharmacovigilance in San Francisco to lead the global safety strategy... ...pipeline. This senior leadership role requires... ...expertise in oncology and regulatory knowledge. The ideal candidate... ...and managing regulatory submissions. #J-18808-Ljbffr...Regulatory
$102k - $139.7k
...Pacific Gas And Electric Company is seeking a Senior Risk & Compliance Analyst based in Oakland, CA. The successful candidate will ensure... ...and evaluating control effectiveness in alignment with regulatory standards. The ideal candidate will have at least 5 years of relevant...SeniorRegulatory$166k - $205k
...RWE Gruppe is seeking a Senior Legislative and Regulatory Rulemaking Manager in Oakland, CA. This full-time role involves leading legislative initiatives and developing regulatory strategies to align with corporate priorities. Responsibilities include policy position development...SeniorRegulatoryFull time- ...strategic Head of Drug Safety &... ...responsible for leading the global safety... ...pharmacovigilance (PV) operations... ...assets. This is a senior leadership role... ...requiring strong regulatory knowledge,... ...PADER, PBRER) Lead signal detection, risk... ...for regulatory submissions (INDs, NDAs)...SeniorRegulatory
$186k - $233k
...experienced Statistical Programmer with over 14 years in oncology trials. The role entails leading studies, collaborating with teams, and overseeing programming support for regulatory submissions in a dynamic environment. This opportunity offers competitive pay, from $186,000...SeniorRegulatory- ...The State of California is seeking a Senior Environmental Scientist (Supervisor) in Sacramento. This role involves leading a team of inspectors, reviewing regulatory compliance, and engaging with stakeholders to manage wildfire risks and improve environmental protection...SeniorRegulatory
$164k - $205k
...harboring mutations in the RAS signaling pathway. The Opportunity... ...oversight of Global Patient Safety operational activities in the... ...Contract Research Organization (PV CRO) in the execution of safety... ...of safety reports to global regulatory authorities, central IRB/...SeniorRegulatoryFull timeContract work$165k - $175k
...Specialist for new developments in California. This role requires an RCFE license and senior living experience, focusing on managing day-to-day operations while ensuring regulatory compliance. The position comes with extensive travel (up to 95%) to different communities...SeniorRegulatory- ...MD required. Oncology submission experience preferable.... ...SRL performs proactive Safety Surveillance (SS) and... ...effect product safety signal detection, risk assessment... ...Unit/Research Unit Leads to meet the BU/RU... ...spontaneous, literature and regulatory cases, other...SeniorRegulatoryRemote workFlexible hours
- Abbott Laboratories in Alameda, CA is seeking a Senior Regulatory Affairs Specialist to support product development and regulatory activities... ...involves providing regulatory input on design, preparing submissions, and ensuring compliance for Class II software medical devices...SeniorRegulatory
$164k - $205k
...harboring mutations in the RAS signaling pathway. The Opportunity... ...oversight of Global Patient Safety operational activities in the... ...Contract Research Organization (PV CRO) in the execution of safety... ...of safety reports to global regulatory authorities, central IRB/...SeniorRegulatoryFull timeContract work$325k - $400k
...stop learning. The Senior Medical Director will... ...cross-functional medical lead for assigned programs,... ...rigor, patient safety, and high-quality data... ...Pharmacovigilance on SAE review, signal detection, and benefit... ...for database lock and regulatory submissions. Cross-Functional...SeniorRegulatoryRemote workFlexible hours$170k - $200k
...Associate Director of Safety and... ...Patient Safety and PV team, supporting both... ...oversight, compliance, signal management, aggregate... ...of PV operations. Lead oversight of... ...presentations and regulatory responses, in collaboration... ...global regulatory submissions (e.g., drafting...Regulatory- ...A healthcare technology company in San Francisco is seeking a Staff Regulatory Affairs Engineer. The role involves leading regulatory submissions for AI/ML software, developing regulatory strategies, and ensuring compliance with FDA regulations. The ideal candidate has...Regulatory
$120k - $170k
...Aisafety, based in Berkeley, California is looking for a (Senior) Recruiting Lead to manage a scalable recruiting process as the organization expands. The ideal candidate will have extensive experience in talent acquisition and will help fill over 40+ positions in the...Senior$169.5k - $248.6k
...people around the world. Purpose The purpose of the Senior Director, Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement... ...clinical development programs, the GRL leads the US submissions and agency interactions. All other agency...SeniorRegulatoryFull timeLocal areaFlexible hours- ...Cedent Life Talent is seeking an experienced Regulatory Manager to join their Regulatory Affairs team in San Francisco. The successful... ...will develop and execute regulatory strategies, manage submissions, and ensure compliance with regulatory standards across therapeutic...RegulatoryWork at office
$173.86k
...including electric standards and process safety, electric design engineering,... ...controls, undergrounding, electric regulatory compliance and electric investment planning... ...to collective bargaining. The Senior Consulting Engineer leads complex engineering projects, is a...SeniorRegulatoryWork at officeLocal areaRemote work$230k - $260k
...As Policy Outreach Lead, you will build relationships... ...in AI policy and AI safety. You will also... ...proposals and drafting submissions for public comment, and... ...safety topics Supporting senior colleagues in external... ...legislative, legal, or regulatory developments in the assigned...RegulatoryWork at officeLocal areaHome officeRelocation package- ...A leading clinical research organization is looking for a Senior Clinical Research Associate to oversee site management for U.S.-based clinical trials. In this... ...relevant bachelor's degree and strong knowledge of regulatory requirements. This position includes the opportunity...SeniorRegulatoryRemote work
$167.5k - $234.5k
Tensec is seeking a Senior Signals Specialist in San Francisco to serve as a technical partner for advertisers, focusing on signal optimization and troubleshooting. The role requires 7+ years of ad tech experience and hands-on knowledge of CAPI and pixel solutions. Key...SeniorFlexible hours$153.83k
...electric standards and process safety, electric design engineering,... ..., undergrounding, electric regulatory compliance and electric investment... ...bargaining. The Senior level engineer job requires mastery... ...and equipment issues. * Lead development, implementation, and...SeniorRegulatoryWork at officeRemote work$119k - $190k
(Senior) Manager, Regulatory Affairs San Francisco, CA or Remote or Hybrid About... ...diseases. Our lead product candidate, BHB-1893... ...gradient response, systolic safety, reversibility and reducing... ...Braveheart Bio's global regulatory submissions, with a primary focus on European...SeniorRegulatoryRemote workFlexible hours$270k - $375k
Senior Director, HEOR - Acoramidis (Global Lead) Mavericks Wanted When was the last time you achieved the impossible... ...alignment with clinical, regulatory, and commercial objectives and driving... ...HEOR contributions to global HTA submissions, pricing, reimbursement, and access...SeniorRegulatoryWork at officeWorldwideFlexible hours$153.83k
...electric standards and process safety, electric design engineering,... ..., undergrounding, electric regulatory compliance and electric investment... ...bargaining. This is a senior-level engineer job that requires... ...and is responsible for leading engineering and design of complex...SeniorRegulatoryContract workFor contractorsWork at officeLocal areaRemote work
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