Pharmacovigilance QA
Seeking an experienced PV QA Consultant to enhance compliance within a global PV system. This role involves leading PV audits, managing compliance across affiliates, and supporting interactions with regulatory authorities. Key Responsibilities: Oversee global PV audit program, ensuring adherence to FDA, EMA, and international PV regulations. Implement and standardize PV systems across affiliates, driving quality and compliance. Support regulatory inspections and manage CAPAs for PV activities. Requirements: Master's in Pharmacy, Life Sciences, or related field. 10+ years in PV QA, with audit and inspection experience. Expert knowledge of global PV regulations; fluent in English (German/French a plus) For further information about this position, please apply with your CV *Please note, only those with the right to work in Switzerland can apply!
Negotiable
Basel
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Sr Manager Drug Safety Operations
Job summary: This role is responsible for assisting in the oversight of all operational activities related to drug safety studies, from start-up to closeout. It involves monitoring clinical trial safety vendor activities and supporting key tasks related to case processing management within the Argus Safety Database, ensuring compliance with global clinical safety and pharmacovigilance regulations, as well as the procedures of the Global Patient Safety (GPS) department. RESPONSIBILITIES: Technical Responsibilities include but are not limited to: Process and evaluate Serious Adverse Events (SAEs) and Adverse Events (AEs) from the time of receipt until case closure in the Argus database, including generating queries, MedDRA coding, and narrative writing. Manage and implement a high standard of case quality review to ensure accurate medical safety data documentation with the support of the Drug Safety Physician. Perform Safety Study Lead tasks, such as reviewing Investigator Brochures and study protocols, and contributing to IND Annual Reports in collaboration with the Drug Safety Physician. Develop study-specific and program-level safety management plans using templates from CRO. Create, review, and update drug safety forms and templates to align with relevant clinical operation documents (e.g., SAE data collection forms and CRFs). Monitor the activities of CROs and partners to ensure compliance with applicable Safety Management Plans (SMPs), Pharmacovigilance Agreements (PVAs), and other contractual obligations. Collaborate with Data Management to carry out SAE reconciliation activities per study-specific plans. Train new safety staff on the Argus system and case processing. Work with other departments (Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, Project Management) to ensure proper collection and management of safety data. Lead cross-functional projects, gather input, and achieve consensus on safety operational topics. Develop and/or update Standard Operating Procedures (SOPs), processes, and practices for study lead and SAE case processing activities, in compliance with drug safety and pharmacovigilance regulations and standards. Manage and execute personal work effectively to achieve departmental goals. Additional duties and responsibilities as assigned. EDUCATION & EXPERIENCE: Education/Experience: BS/BA degree in a related field with a minimum of 9 years of relevant experience; or MS/MA degree in a related field with at least 7 years of relevant experience; or Experience/understanding of study management Experience/The Ideal Candidate: BS or MS in Nursing, Pharmacy, or a related clinical degree with at least eight years of clinical experience. Experience in the biotech/pharmaceutical industry and/or oncology is preferred. Familiarity with the Argus safety database is preferred. Experience in processing clinical trial and spontaneous adverse events.
Negotiable
San Francisco
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Medical Safety Clinician
Utilizes clinical experience and training in patient care to lead or participate in safety signal detection activities aimed at identifying, evaluating, validating, and managing signals for marketed products. This includes conducting individual and aggregate data analyses, interpreting safety signals and trends, and documenting and communicating safety risks in collaboration with key internal and external stakeholders. Draws on previous clinical experience to assess the risks and benefits of medical devices concerning patient safety. May act as a medical reviewer for clinical trials and provide clinical insights to support life-cycle management activities. ESSENTIAL DUTIES Conducts professional medical evaluations of medical device performance, analyzing clinical data from complaints, and assessing the impact on the safety of the company products. Performs searches and reviews of adverse event data, literature, and other relevant safety data for signal surveillance and detection. Collects and summarizes vigilance data for integration into Quality's Post Market-Surveillance Reports. Reviews and contributes to risk and benefit-risk assessments for marketed products, including assessments related to hazardous materials for compliance; oversees safety evaluations impacting patient and donor safety; and prepares risk management plans and reports. Reviews and assists with post-marketing aggregate safety reports (PSURs, PADERs, SUSARs, PBRERs, DSURs, IND annual reports) to ensure consistent communication on safety topics across various regulatory documents; reviews safety sections of the Summary of Safety and Clinical Performance (SSCP) and clinical study documents. Assists in the development of clinical study documents, including informed consent forms and clinical study reports; supports safety-related activities for pre-market applications and regulatory submissions. May contribute to clinical development plans to ensure appropriate medical safety oversight and post-market clinical follow-up (PMCF) studies. Collaborates with cross-functional teams on risk minimization strategies and may provide clinical insights during product development. Participates in relevant Health Hazard Evaluations and field action/recall activities. Engages with Clinical and Scientific Affairs to support product life-cycle management goals. OTHER DUTIES AND RESPONSIBILITIES The GMS Clinician may also perform or assist with medical monitoring functions for clinical studies, including: Reviewing adverse events (AEs) and serious adverse events (SAEs) to assess device and study relatedness and expectedness. Providing input on clinical development plans, protocol design, and risk assessments. Assisting in clinical data management, including MedDRA and WHO DD coding. Reviewing study deliverables such as final narratives and clinical study reports. Analyzing safety and efficacy trends across various clinical trials. Acting as the medical monitor contact for investigators and study sites regarding protocol compliance and participant safety. MINIMUM QUALIFICATION REQUIREMENTS Education A degree appropriate for a licensed healthcare professional (e.g., BSN/RN, MSN/RN, Nurse Practitioner) or equivalent education and experience sufficient to perform essential job functions. An advanced degree in Epidemiology, Biostatistics, Health Surveillance, Patient Safety, or Medical Quality is preferred. Experience Minimum of 3 years of clinical/hospital experience after postgraduate training. Preferred: Two years in a medical safety role within the pharmaceutical, biotech, or medical device sectors, with experience in transfusion medicine, blood banking, cellular therapy, and/or apheresis. Skills Comprehensive knowledge of global regulations and reporting requirements related to medical device and pharmacovigilance, including signal detection and risk management activities. Understanding of drug/device development and lifecycle management processes. Familiarity with therapeutic areas related to the company products. Strong clinical and scientific judgment. Ability to apply medical terminology and concepts in various contexts. Proficient in analyzing datasets, interpreting results, and clearly communicating complex scientific information to diverse audiences. Capable of gathering data from multiple sources, creating case narratives, and conducting risk assessments. Effective teamwork and self-direction, with the ability to work independently. Proficient in relevant PC software applications.
Negotiable
Denver
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