Job Description

Company Description
We are PrimeVigilance (part of Ergomed PLC), 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\xe2\x80\x99s lives.


At PrimeVigilance, Senior PV Officers are independent subject matter experts able to manage a variety of case processing services with full accountability. If you join PrimeVigilance, you can expect to work with teams of different sizes, from small clinical trial, to large, generic post-marketing teams. We are always looking for proactive, capable, and motivated individuals who aim to surpass any target set in front of them. The Senior PV Officer should be a Life science / bio medical background graduate or have other healthcare related degree qualification (chemistry, biology, biotechnology, veterinary science etc.) and have extensive case processing experience. The Senior PV Officer will be working as part of a project team, performing, and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance. Senior PV Officers are expected to reach and maintain a high level of performance within 2 months of being assigned to an ICSR team, following onboarding completion Responsibilities include:

• Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines. As a key member there is expectation to effectively cover all steps of a workflow cycle, except Medical Review.
• Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations, protocol review, Safety Management Plan review)
• Activities related to Periodic Reporting
• Performing other activities undertaken by the project team on behalf of the client and the company acting as a Subject Matter Expert (SME), as well as responding to Client\xe2\x80\x99s queries and attending Client meetings
• Mentoring and training of new and more junior employees within the department, including procedure optimization and development

Qualifications
Requirements:

• Life science / bio medical background \xe2\x80\x93 healthcare related degree (chemistry, biology, biotechnology, veterinary science) and strong demonstrated experience in Pharmacovigilance case processing
• Extensive case processing required
• ARGUS experience preferred
• Time and issue management, delegation, organization and multitasking skills with good attention to detail
• Strong interpersonal and communication skills
• Advanced English skills, both verbal and written, at least C1

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
• Collaborative Partnerships

We look forward to welcoming your application.