Within the Hospital Care division, we are looking for a Safety Scientist (f/m/d) for the Global Pharmacovigilance & Patient Safety department at our Melsungen location as soon as possible. Alternatively, a position as Junior Safety Scientist with at least one year of professional experience (e.g., through an internship or student job) is possible.
The Global Pharmacovigilance and Patient Safety department documents and evaluates reports on drug risks and coordinates the necessary measures according to the guidelines of Good Pharmacovigilance Practice (GVP). Within this department, the Benefit Risk Management Team is responsible for the continuous monitoring of the benefit-risk profile of all B. Braun drugs.
The Benefit Risk Management Team is responsible for signal management, the creation of aggregate reports such as Periodic Safety Update Reports (PSUR), post-marketing surveillance (PMS), and risk management. As a (Junior) Safety Scientist (m/f/d), you contribute to all aspects of signal management, including signal detection, validation, prioritization, evaluation, recommendation of actions, and review of scientific literature for all B. Braun drugs.
Tasks:
* You participate in the establishment, maintenance, and monitoring of the pharmacovigilance system.
* You ensure the ongoing evaluation of the overall safety profile for B. Braun drugs.
* You conduct signal management activities, including signal detection, validation, prioritization, evaluation, and recommendation of actions according to EU-GVP.
* You study global medical-scientific literature to identify safety signals.
* You cooperate with the Global Regulatory Affairs department, including Medical Writing, Medical Scientific Affairs, and other Safety Scientists to review safety data for signal validation, prioritization, evaluation, and implementation of proposed actions.
* You also create and update process documents (e.g., SOPs).
Professional Qualifications:
* You have successfully completed a master's degree in human biology or an equivalent qualification in pharmacy or medicine.
* Ideally, you have already gained initial professional experience in pharmacovigilance, particularly relevant are experiences in signal management.
* Advantageous are also initial knowledge of relevant regulations such as Good Pharmacovigilance Practice Modules VI, VII, IX, EMA regulations, ICH guidelines, or Good Clinical Practice.
* You are proficient in using MS Office (Excel, Word, PowerPoint).
* Your profile is completed by very good English skills; good German skills are also advantageous.
Personal Qualifications:
* You are a communication talent who understands how to interpret and present complex data well.
* You are characterized by your accuracy and organizational talent.
* Your working style is independent, but you can also successfully work in multidisciplinary teams.
* Additionally, you are innovative, work constructively, and value diverse perspectives.
Benefits:
* Corporate networks
* Company pension scheme
* Mobility, e.g., the B. Braun Job Ticket or Job Bike
* Offers around work & family, e.g., holiday care
* Flexible working hours such as flexitime and home office
* Employee discounts
B. Braun Melsungen AG | Laura Frankfurth | +495661713363