PrimeVigilance (part of Ergomed Group), is 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
For our clients
To review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. Review includes coding, assessment of seriousness, listedness/expectedness and company causality, as well as writing of company comments, follow-up questions and analysis of similar events, when required, including the completion of all required supporting documentation such as trackers.
To support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues
To review and provide input in periodic reports
To review literature screening search strategy
To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings
Reviewing database outputs
Can be delegated to support signal detection activities upon acquiring sufficient experience
Proposing a course of action whenever a new risk is identified
For the Company
To contribute to the preparation of PV procedures
The PV Physician will support the Project Manager, as well as the QPPV, on a day to day basis as needed
Qualifications
The PV Physician should be medically qualified as a physician.
Experience in pharmacovigilance is required (Or in clinical medicine)
Excellent interpersonal skills. Ability to plan, organise, prioritise and execute multiple tasks. Ability to work effectively cross culturally and cross functionally and value the importance of teamwork.
Additional Information
We offer excellent chances to progress and develop. We work on a global basis on interesting projects within rare diseases, oncology, and neurology. This is an ideal position to continue developing a career in clinical drug development.
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 Ergomed is a great company to join!
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
We look forward to welcoming your application.
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