EU QPPV & EU Pharmacovigilance Expert Homebased
ProClinical is seeking an EU QPPV & EU Pharmacovigilance Expert for a life science consultancy service. The PV Subject Matter Expert & Qualified Person Responsible for Pharmacovigilance (QPPV) is an EU mandated business critical regulatory and safety governance role with broad responsibilities as defined by European legislation. This role is a remote based role and the candidate must be based in either the UK, Ireland or the Netherlands.Job Responsibilities: * Participates in local or global project teams as a subject matter expert in PV * Participates in/conducts company Signal Management activities. * Participates in the timely planning, development, execution, submission, implementation and maintenance of EU Risk Management Plan(s), periodic aggregate safety reports (PSURs/PBRERs and DSURs) and ad hoc safety reports. * Participates in the creation of response documents to EU Regulatory Authorities in cooperation with other colleagues as appropriate. * Assist in the implementation of compliance standards and facilitate the regular collection of compliance metrics as required. * Constantly maintain inspection readiness for audits and inspections; take part in the preparation and help conduct Pharmacovigilance inspections/audits; support timely execution and submission of responses to inspections/ audits findings; maintain inspection/audit related documentation * Prepare training materials and deliver Pharmacovigilance training for employees. * Establishes and maintains/manages the Marketing Authorization Holder’s (MAH’s) pharmacovigilance program * Ensures that all adverse reactions are collected, collated, and accessible at least at one point within the European Union * Ensures that a detailed description of the PV system is in place * Prepares Individual Case Safety Reports, Periodic Safety Update Reports and company sponsored postauthorizaton safety studies (PASS) * Performs continuous overall pharmacovigilance evaluation during the postauthorization period * Ensures that any requests from the health agency is answered fully and promptly * Oversees the MAH‘s quality control and assurance procedures, SOPs, database operations, contractual arrangements and compliance data * Maintain PV agreements, Safety Data Exchange Agreements (SDEAs), pre-audit questionnaire and data analysis relevant to the company’s quality compliance program. * Constantly maintains inspection readiness for audits and inspections; take part in the preparation and helps conduct Pharmacovigilance inspections/audits; supports timely execution and submission of responses to inspections/ audits findings; maintains inspection/audit related documentation and PSMF files containing audit reports, responses. * Prepares training materials and delivers Pharmacovigilance training for employeesSkills and Requriements: * Bachelor’s degree in a healthcare-related (M.D., RPh, PhD, RN) or Life Science field. * Minimum 5-10 years' experience in the pharmaceutical industry, predominately in Pharmacovigilance, having * worked on both development and marketed products (clinical and post marketing). * Minimum 1 – 3 years experience in the role of (Deputy) QPPV. * Experience in working with Japanese companies preferred. * Experience working in a cross functional team. * Proven expertise in Pharmacovigilance, including risk management - understanding, identifying, mitigating and communicating risks at the study or program level. * Advanced knowledge of regulations governing Pharmacovigilance in the pharmaceutical industry and Research & Development processes in Europe and globally. * Strong organizational, planning, prioritizing and problem-solving skills. * Effective multi-tasking skills, applied in different and complex assignments and ability to work effectively while adhering to strict timelines. * Ability to work both independently and collaboratively and use own initiative. * Ability to communicate effectively both locally and globally, internally and externally. Professionally mature, approachable, flexible and self-motivated. * Open to changes, suggestions and innovations, continuously on the look-out for work processes' improvements. * Tolerance for ambiguity and ability to adapt quickly to a changing business environment. * Highly resilient, tenacious and resourceful. High attention to detail.To Apply:Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.In case you have difficulty in applying or if you have any questions, please call Kevin Hansberry on +44 207 4400 636 or upload your CV on our website - www.proclinical.com. A full job description is available on request.ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.