Consultant Drug Safety

Consultant Drug Safety (Portuguese) Location : Hybrid Type : Full-time The QbD Group supports life sciences companies worldwide from idea to patient. QbD’s team offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in ATMP, Biotech, Medical Devices, In Vitro Diagnostics, Digital Health and Pharma.QbD has affiliates in 8 different countries and can count on the expertise of more than 500 life science professionals and growing. What’s in it for you? Make a real impact: Contribute to shaping the future of the Life Sciences industry by supporting innovative projects and clients across pharma, biotech and medical devices Grow within a community of experts: Benefit from knowledge-sharing, mentoring, and exposure to diverse, challenging assignments that broaden your expertise. Build a meaningful career: As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences. A fair, competitive package: We offer tailored, transparent compensation aligned with your expertise, preferences, and local market regulations — because your contribution deserves to be valued. What you’ll be doing Project managing: Acting as the primary contact point for project-related matters for the client and internally. Maintaining good client relations and ensuring a consistently high quality of work. Preparing project scope and objectives based on signed agreement between the client and QbD Group. Project activity planning, including meeting deadlines and interim milestones Reporting for the client and QbD Group management e.g. preparation of Monthly reports, serving as basis for invoicing. Develop and review Pharmacovigilance Standard Operating Procedures (SOPs/WI) for clients. Cases management control: Data entry and quality control of PV cases in post-marketing and clinical trials, or related to medicinal products, medical devices and cosmetics. PV Assessment of any case of suspected adverse reaction. Direct contact with HCP and patients/consumers. Perform any follow-up activities required. Submission of cases to Eudravigilance, MHRA or any other Competent Authority. Perform bibliographic research in local scientific journals, international journals, MLM service and any other type of search. Management of medical information and answering queries. Review and control of Safety Regulatory intelligence Review and control of Pharmacovigilance agreements Review and control of Pharmacovigilance quality system Support in PV audits and inspections of clients Pharmacovigilance training Perform and manage PV metrics and KPIs linked to projects in charge. Participation in preparation of PV aggregate reports under supervision of Senior Drug Safety Officer) Client Support in Pharmacovigilance inspections and audits for services provided. Elaboration, follow-up and evaluation of the CAPA plan applicable to the project. What you bring Bachelor's degree in Life Sciences or related. Must Master's degree in Pharmacovigilance, Pharmaceutical Industry or related. Desirable. High level of English. Must. High level of portuguese. B2 Must. Advanced informatic skills - knowledge of MS Office. Desirable. Experience in project management. Desirable Knowledge of Good European Pharmacovigilance Practices (GVPs) At least 3 years of experience in Pharmacovigilance, having been involved in: cases management and signal detection Quality knowledge regarding the management of deviations / CAPAs. Desirable Knowledge regarding Eudravigilance requirements for Marketing Authorization Holders (clients) and the processes with the Health Competent Authorities. Desirable. Experience in Pharmacovigilance audits. Desirable