Associate Consultant Drug Safety - German

Overview
The 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.

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 offer an environment to thrive in life sciences.

A fair, competitive package:  Transparent compensation aligned with expertise, preferences, and local market regulations.

Responsibilities

General responsibilities:

The 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.

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 client’s 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 other search types.

Management of medical information and answers to queries.

Review and control of Safety Regulatory intelligence.

Review and control of Pharmacovigilance quality system.

Participation in specific events related to the area of work.

Education & qualifications

Bachelor’s degree in Life Sciences or related field.

Master’s degree in Pharmacovigilance, Pharmaceutical Industry or related (desired).

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

Bibliographic search and database management experience.

Desirable knowledge of European Good Pharmacovigilance Practices (GVPs).

Knowledge regarding Eudravigilance requirements for Marketing Authorization Holders (clients) and the processes with Health Competent Authorities.

High level of English; proficient level of German.

Good teamwork skills and high learning capacity (plus).

Proactive in work groups and participative.

Attention to detail.

Skills and/or experience in the writing of scientific texts (desirable).

Organization ability and task prioritization.

Our culture and values

You’re resilient and tackle challenges with a positive mindset.

You’re curious and always up for learning something new.

You have a no‑non‑sense approach, honest, clear, respectful.

You’re innovative and bring ideas, not just opinions.

Above all, you’re serious about your work, but not too serious about life.

About us
The 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.

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