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SENIOR ASSOCIATE/SPECIALIST, REGULATORY INTELLIGENCE AND ANALYTICS

Descripción de la oferta de empleo

Company Description PrimeVigilance, an  Ergomed Group  company, was established in by Dr.
Miroslav Reljanovic together with co-founder Dr.
Elliot Brown.
PrimeVigilance offers holistic, top quality, cost-effective, innovative safety services for pharmaceutical, generic and biotechnology companies.
Our founders and leaders have an unrivalled reputation in the sector with a network of expert associates across the world.
Job Description Provide intelligence on pharmacovigilance requirements and contribute to the development of the strategy and set up activities for projects.
Perform regular screening/quality control of regulatory legislative requirements updates worldwide and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes Act as a local contact person for pharmacovigilance (or deputy) for Spain Provide internal teams with guidance on national requirements Ensure compliance with company procedures, processes, training records, systems and any other tools Promptly identify and escalate risk/potential risk to the project team which may jeopardise deliverables.
Maintain awareness of allocated tasks and hours and promptly identify and escalate any OoS.
Provide administrative support to BD activities.
Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
Participate in preparation for audits/inspections and provide department representation for assigned projects as required.
Qualifications Degree in Chemistry or Life Sciences, Nursing or equivalent experience Previous experience within the pharmaceutical/CRO industry Good planning and organizational skills  Good written and verbal communication skills to clearly and concisely present information  Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment Good attention to detail  Excellent self-motivation skills Proficiency in English and Spanish, both written and verbal Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint Additional Information What we offer Diverse tasks - data mining, screenings, analysis, requirements review.
Chance to build a broad and comprehensive knowledge on PhV processes and requirements Chance to expand knowledge on other areas covered by Regulatory and Clinical Delivery department i.
.
clinical trials, marketing authorisations, XEVMPD, PV Network A role in development of RI processes in a motivating environment I'm interested I'm interested Privacy Policy
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Detalles de la oferta

Empresa
  • Sin especificar
Localidad
  • En toda España
Dirección
  • Sin especificar - Sin especificar
Fecha de publicación
  • 10/12/2024
Fecha de expiración
  • 10/03/2025
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