Senior Specialist Clinical Safety
Position Overview: The Senior Clinical Safety Specialist is responsible for managing adverse event reporting, device reporting, and safety deliverables for both investigational and marketed products. This role involves creating and implementing project-specific safety plans and overseeing the processing of events and complaints in line with study-specific operational plans. This hybrid role requires a minimum of three days per week in the office in the Greater Boston area. Key Responsibilities: Oversee adverse event processing, including report review, safety query management, and expedited reporting. Determine the type and level of processing required for adverse events. Draft study-specific safety documents and plans (e.g., safety plan, CEC/IMR Charter). Serve as a member of the clinical core team. Conduct Clinical Trial Safety Review meetings. Ensure adjudication and reconciliation of safety events are completed before data snapshots. Provide safety-related input to other study documents and processes as needed (e.g., protocol, CRF design). Manage functional deliverables to ensure study milestones are met on time. Handle additional projects, deliverables, and timelines to support activities within the clinical department.
US$90000 - US$150000 per year
Marlborough
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Director PV Safety Systems
I am partnered with an industry leading biopharma on a search for a Director Safety Systems, reporting into the VP, Drug Safety. This innovative bio-pharmaceutical company is dedicated to developing groundbreaking treatments for metabolic and liver diseases. Their research focuses on creating therapies that address significant unmet medical needs, aiming to improve the quality of life for patients worldwide. With a strong commitment to scientific excellence and patient care, they are at the forefront of advancing medical science in their field. This position focuses on optimizing global safety systems and setting the strategy for PV technology, seeking opportunities for efficiency and innovation. Responsibilities: Lead PV systems management strategically, ensuring alignment with global regulatory requirements. Oversee the implementation, maintenance, and enhancement of pharmacovigilance systems and databases to support drug safety operations, including setting the outsourcing strategy with management approval. Manage the identification and oversight of the safety system vendor, including monitoring Key Performance Indicators to ensure high-quality service and regulatory compliance. Ensure all pharmacovigilance activities comply with global regulatory requirements, including those of the FDA, EMA, and other relevant regulatory bodies, by ensuring the safety system (e.g., Argus) is properly configured and validated to function as designed. Assist in the collection, analysis, and interpretation of safety data from various sources, ensuring accurate and timely reporting of adverse events by obtaining accurate outputs from the safety system. Identify and drive continuous improvements in PV operations through innovative technology solutions, process enhancements, and the use of AI as appropriate. Collaborate with internal and external stakeholders, including clinical development, regulatory affairs, and other internal departments, to ensure effective communication and coordination of safety information. Qualifications: 10+ years of experience in computer systems, with at least 5 years in pharmacovigilance managing safety systems and operations. Expertise in pharmacovigilance safety databases (e.g., Argus, ARISg), safety reporting systems, and data analysis tools. In-depth knowledge of global pharmacovigilance regulations and guidelines, including ICH, FDA, and EMA requirements.
US$225000 - US$250000 per year
Philadelphia
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Manager, Clinical Safety Operations
I am partnered with an industry leading biopharma on a search for a Manager, Clinical Safety - reporting into the Director of PV. This innovative bio-pharmaceutical company is dedicated to developing groundbreaking treatments for metabolic and liver diseases. Their research focuses on creating therapies that address significant unmet medical needs, aiming to improve the quality of life for patients worldwide. With a strong commitment to scientific excellence and patient care, they are at the forefront of advancing medical science in their field. The Manager of Clinical Safety & Medical Operations will be instrumental in supporting the safety assessment, evaluation, and risk management of products at various development stages, as well as participating in safety surveillance activities. Responsibilities: Review ICSRs (including case narratives, causality assessments, and coding) for assigned projects. Oversee clinical pharmacovigilance vendor activities, including assessment, evaluation, tracking, and reconciliation of safety information. Manage the monthly reconciliation process performed by the PV vendor. Assist with Data Monitoring Committee activities as needed. Support other PV compliance activities as required. Qualifications: Minimum of 5 years of experience in drug safety and PV, including case quality control and regulatory submissions of ICSRs worldwide. Ability to interpret health and medical records such as adverse event reporting forms and discharge summaries. Experience with safety databases; familiarity with Argus is a plus but not mandatory.
US$130000 - US$150000 per year
Philadelphia
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Global Safety Officer / Medical Director Drug Safety
I am partnered with a pioneering, global biopharma who has led the industry in remarkable scientific breakthroughs to enhance people's lives. They are currently looking for a Medical Director, Drug Safety to add to their Immunology group. Internal & External Safety Expert Provide pharmacovigilance (PV) and risk management expertise to both internal and external stakeholders. Act as the safety expert for products. Stay informed about the product, its environment, and recent literature. Maintain PV expertise and a thorough understanding of international safety regulations and guidelines. Lead cross-functional Safety Management Teams (SMTs). Communicate and represent PV analyses and positions within project/product teams, safety governance, and benefit-risk governance activities and committees (e.g., Safety Management Committee, Benefit-Risk Assessment Committee), with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations. Offer strategic and proactive safety input into development plans. Support due diligence activities and pharmacovigilance agreements. Signal Detection & Assessment Responsible for signal detection and analysis. Collaborate with the Center of Excellence for Signal Detection, Data Mining, and Safety Epidemiology group. Identify and implement proactive safety analysis strategies to further define the safety profile. Lead aggregate safety data review activities and coordinate safety surveillance activities. Risk Assessment & Risk Management & Benefit-Risk Assessment Provide proactive risk assessment. Co-lead benefit-risk assessment with other relevant functions. Develop risk management strategies and plans and monitor their effectiveness. Collaborate with the Center of Excellence for Risk Management and Epidemiology/Benefit-Risk groups. Submission Activities Represent the safety position in cross-functional submission teams. Ensure the generation, consistency, and quality of safety sections in submission documents. Write responses or contributions to health authorities questions. Support the preparation and conduct of Advisory Committee meetings. Report Writing Document, contribute to, coordinate, review, and/or validate periodic reports, such as RMP updates, IND Annual Reports, Annual Safety Reports/Development Safety Update Reports, and Periodic Safety Update Reports. Serve as the medical safety expert to the GPV Periodic Reports group for assigned projects and products.
US$240000 - US$270000 per year
Boston
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AD/Director PV Operations
The individual will oversee the daily operations of the Pharmacovigilance function, ensuring adherence to standard operating procedures, policies, industry best practices, and relevant regulations. Primary Responsibilities: Oversee the daily management and execution of pharmacovigilance (PV) operations. Ensure compliance with regulatory requirements, PV agreements, and internal SOPs. Act as a representative for the Drug Safety and Pharmacovigilance departments on clinical development teams. Supervise the processing of Serious Adverse Events (SAEs) by outsourced vendors and monitor compliance operations. Develop and implement strategies to maintain high-quality standards by analyzing and mitigating compliance risks. Manage SAEs, including case triage, data entry, coding review, and narrative writing. Provide support for safety operations in external submissions, signal detection, and risk management planning. Assist in the preparation of periodic safety reports (e.g., DSUR, PSUR). Ensure the compliant exchange of safety data between the company and its partners. Collaborate with the quality management system in Drug Safety to ensure department standards are met, including training, performance monitoring, continuous improvement actions, and good documentation practices. Work with the QA department to maintain high PV inspection readiness across all regions/countries. Collaborate with contract service providers for case processing, aggregate reporting, and quality management activities. Manage the performance of PV systems. Support root cause analysis of deviations relevant to PV systems. Participate in regulatory inspections and company audits, including FDA/MHRA/EMA PV inspections. Prepare responses to audit findings related to the PV department. Manage reconciliation activities with other departments and vendors. Provide project management support for NDA/MAA submission activities and prepare safety data submissions. Support cross-functional teams in patient narrative efforts. Provide strategic oversight of vendors. Manage the quality and compliance of assignments, including training and mentoring.
US$170000 - US$230000 per year
Utah
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