Senior Associate/Specialist, Regulatory Intelligence and Analytics 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
The Senior Associate, Regulatory Intelligence and Analytics is responsible for completing regulatory deliverables based on an established regulatory plan. They also serve as a liaison between regulatory and other functional areas including external partners, clients, authorities and/or consultants in the planning, organizing, and preparing of regulatory deliverables following project, corporate and industry regulatory strategies.
Role and Responsibilities
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.
Provide feedback on performance of vendors to aid their assessment.
Qualifications
Degree in Chemistry or Life Sciences, Nursing or equivalent experience
Previous regulatory 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
Additional Information
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.
We offer:
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
We look forward to welcoming your application.
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