Safety Scientist - Melsungen, Deutschland - B. Braun Melsungen AG

B. Braun Melsungen AG

Geprüftes Unternehmen

Melsungen, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Within Global Pharmacovigilance & Patient Safety as part of Quality Management Hospital Care, we are looking for a Safety Scientist (f/m/d) as soon as possible.

As Safety Scientist (f/m/d) you will contribute to all aspects of safety science activities including safety surveillance, signal detection, validation, prioritization, assessment, recommendation for actions and review of scientific literature for all B.

Braun products.

As a global safety scientist, you will be involved in the implementation and validation of a new signal management tool and automation of this process.

Further, you will play an important role in ensuring the safety and contribute to the regulatory compliance of the B.

Braun portfolio.

Duties and responsibilities:

You ensure ongoing evaluation of the overall safety profile for B. Braun marketed products
You identify and evaluate safety signals through assessment of individual case safety reports and aggregate data
You review global literature for identification of potential safety concerns and continuously update the benefitrisk assessment of medicinal products
You develop proposals for necessary drug safety measures and coordinate these measures with the responsible authorities
The collaboration with Global Regulatory Affairs department, Medical Scientific Affairs, Risk Management Physicians and other safety scientists to review safety data for signal validation, prioritization, assessment and proposed action plans is also one of your tasks
Additionally, you coordinate and document agreed drug safety measures with comarketing companies and authorities and participate in the preparation and updating of process documents (e.g., SOPs)
You produce high quality, accurate, and fitforpurpose evaluation documents with clear conclusions in response to internal or regulatory authority request for safety reasons
Finally, you contribute to the maintenance of the Pharmacovigilance System Master File (PSMF) and participate in the establishment, maintenance and monitoring of the pharmacovigilance system

Professional competencies:

You have successfully completed a (bachelors) degree in pharmacy, human biology, medicine, veterinary medicine or a related field
You have several years of significant work experience within pharmacovigilance primarily in safety signal management
You can provide intensive knowledge of pharmacovigilance regulations (Good Pharmacovigilance Practice, EMA regulations, GVP modules VI, VII, IX, ICH guidelines, Good Clinical Practices)
You feel comfortable interpreting and presenting data
Your English skills on a verbal and written level are excellent

Personal competencies:

Communication is your strong suit
You thrive on working independently and collaboratively in a multidisciplinary team
Attention to detail and strong organizational and prioritizing skills come naturally to you

What we offer:

Become part of a corporate culture that actively promotes constructive exchanges between colleagues, customers and partners. Work with us to improve people's lives in the long term.

We can offer you interesting, varied tasks and excellent opportunities for advancement, as well as an attractive salary with extensive benefits, all within a dynamic family-owned company.