Pharmacovigilance Officer

Pharmacovigilance Officer (senior level position)Apply to join Prime Vigilance.Company DescriptionWe are Prime Vigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in ****.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.Prime Vigilance 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 DescriptionAt Prime Vigilance, PV Officers are independent case-processing team members who are expected to manage a variety of case-processing services with full accountability.If you join Prime Vigilance, you can expect to work with teams of different sizes, from small clinical trial teams 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 PV Officer should be a life-science / bio-medical background graduate or have another healthcare-related degree qualification (chemistry, biology, biotechnology, veterinary science etc.) and have demonstrated strong experience with several years in case-processing.The PV Officer will be working as part of a project team, performing, and supporting contracted pharmacovigilance activities on behalf of Prime Vigilance.ResponsibilitiesProcessing of Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, Prime Vigilance procedures and in accordance with client-specific requirements and timelines.Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations).Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc.).Mentoring and training of new and more junior employees within the department, including procedure optimisation and development.QualificationsLife science / bio-medical background – healthcare-related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case-processing.Demonstrated case-processing experience.Time and issue management, delegation, organisation and multitasking skills with good attention to detail.Strong interpersonal and communication skills.Advanced English skills, both verbal and written, at least C1.Additional InformationWhy Prime Vigilance?We prioritise diversity, equity, and inclusion by creating an equal-opportunity 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 in improving the lives of those around us.We OfferTraining 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.Core ValuesQualityIntegrity & TrustDrive & PassionAgility & ResponsivenessBelongingCollaborative Partnerships