Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Global Safety Leader - Deputy Director (m/f/d)

Your tasks and responsibilities

 

  • Be responsible for the safety assessment activities of assigned products and lead the pharmacovigilance benefit risk management processes
    including chairing safety management teams and benefit risk management teams
  • Identify, prioritize and analyze clinical safety signals as well as ensure appropriate clinical safety risk communication and escalation
  • Perform ongoing review of emerging safety data from various sources including single case reports, product technical complaints and published
    literature and reports from partner functions
  • Work with the systems and operations teams to develop and continuously maintain and improve effective systems to ensure single cases fulfill
    the requirements for signal detection and aggregate report compilation through targeted training
  • Produce high quality aggregate reports and responses to regulatory queries and ensure adequate labeling of safety related information as well as the
    effective and timely delivery of aggregate reports, benefit risk statements, safety sections of DCSI and relevant position paper and justification documents, etc.
  • Liaise with internal and external experts as well as key opinion leaders (KOLs) to obtain specialized medical expertise as appropriate
  • Provide medical safety oversight of clinical study data in the context of the medical review process for clinical studies
  • Plan and deploy skilled resources against project priorities in consultation with the head of pharmacovigilance benefit risk management

 

Who you are

 

  • Medical degree, e. g. PhD or Doctor of Osteopathic Medicine (m/f/d)
  • Long-term professional experience in pharmaceutical industry, thereof several years of clinical and pharmacovigilance experience
  • Specialty certification preferred
  • Appropriate experience with Regulatory Agency and KOL interactions as well as a good knowledge of pharmacovigilance relevant regulations
    and Bayer Pharma standards
  • Proven evidence of effective delivery of high quality safety relevant documents as well as knowledge of relevant concepts in data
    management and systems, pharmacoepidemiology and statistics
  • Strong influencing skills with the ability to explain and defend a position in the face of opposition
  • High ability to solve problems and to structure and simplify complex tasks
  • Fluency in English, both written and spoken

 

 

Your application

Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people’s lives? Then send us your online application including cover letter, CV and references.

 

 

 

Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination. 

Country: Germany
Location: Berlin
Reference Code: 44710
Functional Area: [sap_fa_30]
Entry Level: 5