Requirements: English
Company: PrimeVigilance
Region: Milan , Lombardy
Company DescriptionWe are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We have achieved consistent global growth, with staff across Europe, North America, and Asia, providing services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.PrimeVigilance supports pharmaceutical and biotechnology partners of all sizes, maintaining long-term relationships and becoming a global leader in the field. We cover all therapy areas, including medical devices. We invest in our staff through excellent training and development, and prioritize employee well-being, mental health, and work-life balance to ensure high-quality client service.Job DescriptionThe Senior Pharmacovigilance (PV) Physician I is responsible for medical review of ICSRs, writing/reviewing signal detection reports, aggregate reports (DSURS, PSURS, PBRERs, PADERS), reviewing RMPs, and mentoring junior PV Physicians. The role also involves supporting the QPPV in medical and safety issues as required by the company or client.Responsibilities for the ClientReview and approve post-marketing ICSRs and SAE reports, including coding, seriousness, listedness/expectedness, causality assessment, and documentation.Complete adverse event trackers for all ICSRs.Support or act as a Qualified Person for Pharmacovigilance in medical understanding and evaluation of safety issues.Review literature search strategies and articles for safety-related findings.Contribute to Risk Management Plans and responses to regulatory requests.Potentially act as EEA QPPV or Deputy for up to two clients.Review and input into safety update reports and reference safety information.Lead specific pharmacovigilance areas requiring medical input.Participate in Drug Safety Review Committee activities, signal detection, and risk evaluation.Signal Detection ActivitiesParticipate in signal detection meetings and review reports.Evaluate and categorize signals.Propose actions for identified signals.Assist in preparing benefit-risk reports.Support project planning and quality oversight of signal detection activities.For The CompanySupport PV procedures development.Mentor and train junior PV Physicians.Provide medical advice to project teams daily.Develop company procedures related to signaling.Support the Director of Projects and QPPV in daily operations and training efforts.QualificationsMedical qualification as a physician.Previous pharmacovigilance experience.Ability to review PBRERs, DSURs, and expertise in signal detection.Excellent interpersonal, planning, organizational, and communication skills.Fluent in English (spoken and written).Proficient in MS Office.Additional InformationWe value diversity, equity, and inclusion, fostering a supportive environment for growth. We offer training, career development, and a collaborative, global work environment. Our core values include Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, and Collaboration.Join us to make a positive impact in patients'' lives. We look forward to your application.#J-18808-Ljbffr