Associate Consultant Drug Safety German

Location: Hybrid - Madrid
Type: Full-time

The QbD Group supports life sciences companies worldwide from idea to patient. QbDs team offersknowledge&tailored (software) solutionsin development clinical regulatory & compliance production and distribution for companies active inATMP 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.

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.

General Responsibilities:

• The performance of tasks and duties of instrumental and highly predictable content in accordance with previously established instructions according to the rules guidelines or ordinary procedures in regular use in the company tasks for which they have the direct supervision of the immediate superior.

• Every staff member of the Pharmacovigilance Department should be trained in each applicable SOP and WI according to general procedure

• Depending on the projects specific training in applicable clients SOPs is also mandatory.

Specific responsibilities:

• 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 searches in local scientific journals international journals MLM service and any other type of search.

• Management of medical information and answer of queries.

• Review and control of Safety Regulatory intelligence

• Review and control of Pharmacovigilance quality system

• Participation in specific events related to their area of work.

Education:

• Bachelors degree in Life Sciences or related

• Masters degree in Pharmacovigilance Pharmaceutical Industry or related. Desirable.

Experience:

Work experience as Trainee or Junior within pharmacovigilance and updated knowledge in Quality Assurance for the Pharmaceutical Industry is a plus.

• Bibliographic search and database management. Desirable

• Knowledge of European Good Pharmacovigilance Practices (GVPs).

• Knowledge regarding Eudravigilance requirements for Marketing Authorization

• Holders (clients) and the processes with the Health Competent Authorities. Desirable

Languages:

• High level of English. Must.

• Proficient level of German. Must.

Other:

• Good teamwork skills and high learning capacity is considered a plus.

• Participative and proactive in work groups.

• Attention to detail

• Skills and/or experience in the writing of scientific texts. Desirable

• Organization ability and task prioritization.

Our culture is driven by values If this sounds like you youll fit right in:

• Youre resilient and tackle challenges with a positive mindset

• Youre curious and always up for learning something new

• You have a no non-sense approach honest clear respectful

• Youre innovative and bring ideas not just opinions

• And above all youre serious about your work but not too serious about yourself

We support 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.

We believe in JPEG:
Joy. Partnership. Going the Extra Mile. Getting Things Done.

You wont just be taking a job youll be joining a community where people grow laugh build and contribute to something bigger.

Interested Lets talk.
Send us your CV and motivation letter. You could be the next one to join the QbD family.