Specialist, Regulatory Intelligence and Analytics

Perform quality control of regulatory intelligence screening of legislative requirements updates and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.

Provide internal teams and Clients with expertise and 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 support to proposal development and input to budgets, provide department representation to BD meetings as required.

· 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.

Qualifications

Degree in Chemistry or Life Sciences, Nursing or equivalent experience

Minimal previous experience within the pharmaceutical/CRO industry Good knowledge of ICH GCP and/or GVP and national regulations for territories of competency

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

Basic understanding of ICH GCP across all areas

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.e. clinical trials, marketing authorisations, XEVMPD, PV Network
• A role in development of RI processes in a motivating environment

About the Company

We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. 

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device. 

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. 

Come and join us in this exciting journey to make a positive impact in patient’s lives.