Senior PV Operations Lead — Global Safety & Compliance
Socket.dev
Amylyx Pharmaceuticals is seeking a Senior Manager of Pharmacovigilance Operations to lead day-to-day PV activities for both investigational and marketed products. You will drive data quality, oversee safety reporting, and coordinate with internal teams and external vendors in a fast-paced biotech environment. The role emphasizes supervision, process improvement, and ensuring regulatory compliance across global PV programs. #J-18808-Ljbffr Socket.dev
$162k - $223k
...Role The SPARQ (Medical Safety, Pharmacovigilance,... ...Authoring Regulatory Operations, Quality & Compliance) Strategy, Operations & Communications Lead will drive strategy... ...communications that support senior leadership decision-... ...the priorities of a global, technical, medical...SuggestedTemporary workLocal area- ...Cambridge, MA is seeking a Senior Pharmacovigilance Scientist to lead safety signal management, author aggregate... ...literature, and support PV activities in trials and on... ...staff, collaborate with Global Safety Officers, and ensure compliance with global safety regulations...Senior
- ...The world’s oceans convey 90% of global commerce. We’re applying... ...workboats the intelligence to operate autonomously and remotely, and which increases safety for maritime crews, and radically... ...vessels when required. Ensure compliance with all USCG regulations and company...SuggestedFull timeWork at officeRemote workFlexible hours
$120k - $202.5k
...Street’s Cyber Data & Analytics (CyberDNA) team is seeking a Global Operational Excellence Lead to establish world-class operational governance,... ...Management, Engineering, Security Operations, Risk, Audit, and Compliance teams to improve operational effectiveness.Drive...SuggestedFull timeTemporary workWork at officeLocal areaFlexible hoursShift work2 days per week- The EHS Regional Director at SBM Management Services, LP will lead comprehensive environmental, health and safety programs across multiple sites, ensuring compliance with OSHA and federal regulations while fostering a culture of safety. Travel is required and the role focuses...Senior
$220k - $340k
...building an industry-leading pipeline of oral... ...About the RoleThe Global Safety Officer (GSO)... ...scientist who can operate with the rigor of... ...Medical Director vs. Senior Medical Director)... ...DMCs)Case-Level & Compliance OversightProvide medical... ...partnership with PV operationsEnsure...Senior$148.49k - $159.65k
...seeking a Controller to oversee all financial operations, including accounting management and... ...extensive experience in financial reporting and compliance under U.S. GAAP. Responsibilities include managing the accounting team, leading financial forecasts, and ensuring...Senior- Job Title: Strategic Planning & Operations Team Lead, Global HEVA - Specialty CareLocation: Cambridge, MA or Morristown, NJ (hybrid - 3 days a... ...departmental processes; project and financial management; and compliance and audit readiness. This role also serves as a critical...Contract workTemporary workFor contractorsWork at office3 days per week
- ...is what you will do: The Global Safety Program Lead, Senior Director is accountable to... ...Lead, Senior Director will operate according to the highest ethical, quality and compliance standards in compliance as... ...compliance and adherence to PV regulations of the assigned...SeniorHourly payTemporary workLocal area
- ...Flagship-founded biotechnology company, seeks a Lab Operations Manager to oversee facilities, equipment, safety, and vendor performance in a fast-paced lab. The... ..., with hands-on experience in regulatory compliance, LIMS, and cross-functional collaboration. You will...
$99.47k - $141.8k
Mass General Brigham is seeking a Senior Contract Compliance Specialist based in Somerville, MA. The role entails overseeing data management of agreements and ensuring compliance while driving revenue through effective contract monitoring and reporting. Interested candidates...SeniorContract work- Scorpion Therapeutics is seeking a Lab Operations Manager to oversee laboratory facilities and ensure compliance within a biotech setting, supporting innovative genetic... ...medicines. You will manage lab processes, equipment, safety programs, vendor relations, permits, shipments,...
$212k - $333.19k
...shine? Join us as a Senior Director, Pharmacovigilance Process Lead in our Cambridge,... ...work. Certified as a Global Top Employer, we... ...Pharmacovigilance (PV) Process Lead:Owns... ...Global Development Operations, Clinical Science,... ...and advance patient safety across the business...SeniorMinimum wageTemporary workWork at officeLocal areaRemote work- ...Corporation (NYSE: CBT) is a leading global specialty chemicals and... ...global trends that impact their operations.If you do not meet every requirement... ...apply! Cabot is seeking a Senior Director of Process... ...experience.Risk, Controls & Compliance Partner with Internal Audit,...SeniorFull timeLocal areaFlexible hours
- ...Eurofins believes it is a global leader in food,... ...over 50 countries and operating more than 800 laboratories... ...to evaluate the safety, identity, composition... ...services, as one of the leading global emerging players... ...Monitor team training and compliance, ensuring readiness...Full timeWork at officeMonday to FridayDay shift
- ...Pharmaceuticals in Cambridge, MA is seeking a Senior Manager, Pharmacovigilance Operations to lead and optimize day-to-day... ...will oversee ICSR processing, safety reporting, vendor governance, and... ...reconciliation while ensuring regulatory compliance and quality. This role requires...SeniorRemote job
- Novartis in Cambridge, MA seeks a senior Nonclinical Safety leader to drive global safety programs across modalities, ensuring regulatory-compliant strategies... ...functional R&D teams and Health Authorities. You will lead safety strategy, author IND/NDA sections, influence...Senior
- ...Job Description: This role is within the Global Regulatory Affairs (GRA) Chemistry... ...Responsibilities: With some supervision, leads the execution of regulatory CMC investigational... ...probability of regulatory success and regulatory compliance. Ability to draw from precedents and...Senior
- ...-to-end (E2E) pharmacovigilance (PV) processes for critical cross-functional... ...(Regulatory, Quality Assurance, Global Development Operations, Clinical Science, Medical... ...pharmaceutical industry with focus on drug safety and pharmacovigilance. Senior leadership experience managing...SeniorLocal area
- Reference: PR/609787_1789151666A global consumer products leader is seeking a Senior Global Supply Planning Manager to... ...and equipment portfolio. This role leads a team responsible for balancing... ...'s degree in Supply Chain, Operations, Business, or a related field.8+...Senior
- ...Senior Vice President, Global Regulatory Affairs About the Company A clinical... ...a proven track record in leading global oncology regulatory... ...regulatory pathways and ensuring compliance as the organization... ...toward pivotal trials. Functions ~ Operations ConfidentialSenior
- Insurify is seeking a Senior HR Business Partner to support the Support... ...Sofia, Bulgaria, delivering globally accountable HR programs and... ...-paced environment. You’ll lead performance management,... ...and regional teams to ensure compliance and local adaptation. #J-188...SeniorLocal area
$200k - $240k
...experienced Associate Director, Clinical Operations to oversee clinical trials from start-up... ...Sciences. The Associate Director will lead the operational aspects of Phase I-III trials... ...manage vendor relationships, and ensure compliance with ICH-GCP guidelines. The salary...Senior$84.13 per hour
...(NYSE:AMRC) is a leading energy solutions provider... ...net zero in the global energy transition.... ...constructing and operating tailored smart... ...actively seeking a Senior Director, Business... ...are attained Ensure compliance with company,... ...industry, and regulatory safety standards and...SeniorFull timeContract workLocal areaRemote work$88.5k - $147.5k
...sciences, ensuring drug safety and efficacy or... ...will support vivarium operations by managing an assigned... ...operational processes are in compliance with local and federal... ...As needed, Ops team lead may need to work on... ...participation in Pfizer’s Global Performance Plan with...Permanent employmentFull timeH1bWork at officeLocal areaRemote workVisa sponsorshipWork visaRelocation packageWeekend work$159k - $179k
Senior Manager, Pharmacovigilance Operations Cambridge, MA Amylyx has an audacious... ...member of the Patient Safety and... ...timely execution of global pharmacovigilance activities... ...marketed products in compliance with Amylyx procedures... ...trends or risks to PV leadership....SeniorLocal areaRemote work$86k - $143k
...time, Permanent /RemoteResponsible for the clinical operations of a project within a defined regional/global level. Provides oversight of project deliverables,... ...of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations...SeniorPermanent employmentFull timeTemporary workLocal area$55 - $65 per hour
Clinical Contract Manager (Global Clinical Development Operations) 1 day ago Be among the first 25 applicants... ...contract signature process to ensure compliance with the contract approval... ...R&D Legal in addition to the study leads. The Clinical Contract Manager is...Contract workWorldwide- Takeda in Cambridge, MA is seeking a Senior Director, Pharmacovigilance Process Lead to own end-to-end PV processes, drive strategy, and ensure regulatory compliance across cross-functional teams.... ...ensure inspection readiness and patient safety. #J-18808-Ljbffr Takeda
$140 per hour
Global Medical Affairs Operations ManagerMedela LLCSalary starting at $140KTravel 30%Maternal & Infant Health... ...Manager. This person will lead the execution of global Medical Affairs... ...environmentsFamiliarity with industry compliance standards including MedTech Europe,...Full timeLocal areaWorldwide
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