Senior Associate, Regulatory Intelligence and Analytics

Company Description

We are PrimeVigilance (part of Ergomed Group), a specialised midsize 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, wellbeing 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 highquality client service can be achieved.

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

Job Description

Provide intelligence on requirements and contribute to the development of the strategy and set up

activities including Regulatory Management Plan, joint operating procedures, POAs and core

documents. Support identification of issues.

· 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 riskpotential 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 auditsinspections and provide department representation for

assigned projects as required.

Qualifications

Degree in Chemistry or Life Sciences, Nursing or equivalent experience

Previous experience within the pharmaceuticalCRO industry not required, however preferred

Good planning and organizational skills

Good written and verbal communication skills to clearly and concisely present information

Strong interpersonal skills in a fastpaced, deadline oriented, and changing environment

Good attention to detail

Excellent selfmotivation skills

Proficiency in English, both written and verbal

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