Pharmacovigilance Officer

6 days ago


Guildford, United Kingdom Ergomed Full time

At PrimeVigilance 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 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 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 demonstrated 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 PrimeVigilance.  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 an expectation to effectively cover all steps of a workflow cycle except Medical Review. 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 optimization and developmentQualifications : Life 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 organization and multitasking skills with good attention to detail   Strong interpersonal and communication skills   Advanced English skills both verbal and written at least C1Additional 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. 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.Remote Work : YesEmployment Type : Full-time Key Skills Cluster,IT,B2C,Key Account,AutoCAD Drafting Experience: years Vacancy: 1



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