Senior Associate/Specialist, Regulatory Intelligence and Analytics

PrimeVigilance, an Ergomed Group company, was established in 2008 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.

• 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