Senior Associate, Regulatory Intelligence and Analytics

Company Description
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.

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 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.

Qualifications

• Degree in Chemistry or Life Sciences, Nursing or equivalent experience
• Previous experience within the pharmaceutical/CRO 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 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

Additional Information

Why PrimeVigilance
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

The Roll Offers

• 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 department i.e. clinical trials, marketing authorisations, XEVMPD, PV Network
• A role in development of RI processes in a motivating environment
• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships

We look forward to welcoming your application.