04 ago
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Qbd Group | Spain
|
Madrid
04 ago
Qbd Group | Spain
Madrid
ph3Overview /h3 pThe QbD Group supports life sciences companies worldwide from idea to patient. QbD’s team offers knowledge and 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. /p pQbD has affiliates in 8 different countries and can count on the expertise of more than 500 life science professionals and growing. /p h3What’s in it for you /h3 ul libMake a real impact: /b Contribute to shaping the future of the Life Sciences industry by supporting innovative projects and clients across pharma, biotech, and medical devices. /li libGrow within a community of experts: /b Benefit from knowledge‑sharing, mentoring, and exposure to diverse, challenging assignments that broaden your expertise. /li libBuild a meaningful career: /b As an ambitious and pioneering company, we offer an environment to thrive in life sciences. /li libA fair, competitive package: /b Transparent compensation aligned with expertise, preferences, and local market regulations. /li /ul h3Responsibilities /h3 pbGeneral responsibilities: /b /p ul liThe performance of tasks and duties of instrumental and highly predictable content in accordance with previously established instructions, rules, guidelines or ordinary procedures in regular use in the company, under direct supervision of the immediate supervisor. /li liEvery staff member of the Pharmacovigilance Department should be trained in each applicable SOP and WI according to general procedure.
/li liDepending on the projects, specific training in applicable client’s SOPs is also mandatory. /li /ul pbSpecific responsibilities: /b /p ul liCases 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. /li liPV assessment of any case of suspected adverse reaction. /li liDirect contact with HCP and patients/consumers. /li liPerform any follow‑up activities required. /li liSubmission of cases to Eudravigilance, MHRA or any other competent authority. /li liPerform bibliographic searches in local scientific journals, international journals, MLM service and other search types. /li liManagement of medical information and answers to queries. /li liReview and control of Safety Regulatory intelligence. /li liReview and control of Pharmacovigilance quality system. /li liParticipation in specific events related to the area of work. /li /ul h3Education qualifications /h3 ul liBachelor’s degree in Life Sciences or related field. /li liMaster’s degree in Pharmacovigilance, Pharmaceutical Industry or related (desired).
/li liWork experience as Trainee or Junior within pharmacovigilance and updated knowledge in Quality Assurance for the Pharmaceutical Industry (plus). /li liBibliographic search and database management experience. /li liDesirable knowledge of European Good Pharmacovigilance Practices (GVPs). /li liKnowledge regarding Eudravigilance requirements for Marketing Authorization Holders (clients) and the processes with Health Competent Authorities. /li liHigh level of English; proficient level of German. /li liGood teamwork skills and high learning capacity (plus). /li liProactive in work groups and participative. /li liAttention to detail. /li liSkills and/or experience in the writing of scientific texts (desirable). /li liOrganization ability and task prioritization. /li /ul h3Our culture and values /h3 ul liYou’re resilient and tackle challenges with a positive mindset. /li liYou’re curious and always up for learning something new. /li liYou have a no‑non‑sense approach, honest, clear, respectful. /li liYou’re innovative and bring ideas, not just opinions. /li liAbove all, you’re serious about your work, but not too serious about life. /li /ul h3About us /h3 pThe QbD Group supports life sciences companies from idea to patient — offering tailored solutions in development, clinical, regulatory, compliance, production, and distribution. With 500+ experts across 8 countries, we help drive innovation in ATMP, biotech, medical devices, diagnostics, digital health, and pharma. /p /p #J-18808-Ljbffr
📌 Associate Consultant Drug Safety - German (Madrid)
🏢 Qbd Group | Spain
📍 Madrid