Full-Time Regulatory Intelligence Analyst
Ergomed is hiring a remote Full-Time Regulatory Intelligence Analyst. The career level for this job opening is Experienced and is accepting Spain based applicants remotely. Read complete job description before applying.
Ergomed
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Job Details
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.
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.
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.e. clinical trials, marketing authorisations, XEVMPD, PV Network.
A role in development of RI processes in a motivating environment.