Please see the following for the qualifications and skills we seek for this role.Education & Experience MD/Pharm D or other advanced degree in clinical sciences with significant experience working in drug safety/PV or a related field in the biopharma industry, clinical research, health administration, health … policy, or academic or subspeciality medicine. Clinical experience is preferred.Knowledge & Other Requirements Knowledge of the drug development process, GoodClinical Practices (GCP) and Good Pharmacovigilance (GVP), including worldwide PV regulations and their application to safety science activities (aggregate PV reports, risk management plans, signal detection, clinical trials and clinical development).In-depth understanding of observational studies used in pharmacoepidemiology and ability to provide sound critique of such studies.Strong knowledge of statistical methods used in PV.Proven abilities to make significant contributions to Patient Safety (PS) strategic planning and lead significant process improvements in PS.Exceptional interpersonal more »
work in a multidisciplinary environment Effective verbal and written communication skills Understanding of principles of audit and clinical governance Desirable Previous audit completed GCP certificate of GoodClinicalPractice Communication Essential Demonstrable skills in written and spoken English that are adequate to enable effective communication about more »
implement comprehensive quality management strategies, policies, and procedures to ensure compliance with regulatory requirements (e.g. FDA, EMA, etc.) and industry standards (e.g. GMP, GDP, GCP). Provide leadership and direction to the quality assurance and quality control teams, fostering a culture of quality excellence, accountability, and continuous improvement. Establish and more »
relevant experience.• BA/BS with 10+ years’ relevant experience.• Extensive drug safety or related experience in the biopharma industry, at a regulatory agency, clinical research or related medical/healthcare environment.• Extensive experience in drug safety signal detection, benefit-risk evaluation, and authoring drug safety risk management plans … oversight.Knowledge & Other Requirements• Recognized expert in PV, regulations, signal detection, clinical trials and clinical development.• Expert knowledge of the drug development process, GCP and GVP, including worldwide PV regulations and their application to safety science activities (signal detection,clinical trials and clinical development).• Expert knowledge more »
Device QA department Working knowledge, within Pharmaceutical/Medical Device business) of GxP and Quality related regulations and standards Essential: ISO 9001, ISO 13485, GCP, Desirable: ISO 21CFR Part 820, ISO17025, Clinical Trials experience, ISO13485 Lead auditor (external audits more »
Assurance department. - Knowledge of GxP and Quality related regulations and standards within the Pharmaceutical/Medical Device industry. - Familiarity with ISO 9001, ISO 13485, GCP is essential. - Knowledge of ISO 21CFR Part 820, ISO17025, Clinical Trials experience, ISO13485 Lead auditor would be beneficial. Interested or know someone who might more »
debilitating disease areas. Our guiding principles, centred around Integrity and Patient-Centricity, are at the heart of everything we do. Job Purpose Lead all Clinical Data Management (CDM) lifecycle activities from protocol inception to database delivery for numerous global studies via oversight of multiple vendors and internal/external … database locks. Participates in Service Provider selection, evaluation and management, including reviewing and providing input to scope of work. Coordinates user acceptance testing for clinical databases. Contributes to global and sub functional working groups and initiatives. Responsibilities Responsible for delivery of clinical global study databases and specific study … is an essential part of the position Working as the sole Data Manager within the Team Key skills and experience In depth knowledge of GCP and current legislation. Working knowledge of Medidata Rave ( desirable but not essential) and IBM databases Experience of delivering global clinical studies across different phases more »
Cambridgeshire and Peterborough NHS Foundation Trust
to improve the health and wellbeing of the people we care for, as well as supporting andempowering them to lead a fulfilling life. Our clinical teams deliver many NHS services, not only via inpatient and primary care settings, but also within the community. These services include children's, adult … Qualifications Essential Post graduate qualification in a field relevant to research A degree in law or equivalent qualification Desirable Evidence of continuing professional development GCP Trained Knowledge & Skills Essential Knowledge of clinical research governance Ability to communicate, negotiate and influence effectively as appropriate at all levels and be persuasive … Experience Essential Experience of working with contracts Experience of negotiating contracts in a life science or research setting Desirable Experience of working in a clinical research environment in an NHS Trust, University, pharmaceutical company, charity or other organisation Experience of analysing and interpreting complex contractual terms and/or more »
delivering aspects of care in community settings which supports the Trust's vertical integration strategy. Main duties of the job Duties & Responsibilities The Direct Clinical Care PA's will consist attending on the ward, Neonatal Unit and Children's Assessment unit along with 1 in 10 night on call … to reflect the needs of the department, ensuring that contracted work is appropriately remunerated. An initial job plan review will be undertaken by the Clinical Director after 3 months and annually thereafter, or if the work pattern changes. Any additional PAs contracted by the Trust will be agreed as … higher degree Sub speciality interest in Neurology/cardiology , Acute Paediatrics or Neonatology Management/Audit Essential Participation in research and audit projects Desirable GCP training & Enthusiasm for clinical research Teaching Research/Publications Essential Enthusiasm to teach medical students, junior doctors and other staff on General paediatrics Desirable more »
