Associate, 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.

• Perform regular screening of regulatory legislative requirements updates and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes
• 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
• Provide feedback on performance of vendors to aid their assessment

Communicate suggestions for changes to departmental/company processes/procedures and contribute to department initiatives.

Degree in Chemistry or Life Sciences, Nursing or equivalent experience

Minimum previous work experience preferable but not required; No previous experience within the pharmaceutical/CRO industry necessary

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, 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