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

Your tasks and responsibilities

You report to the supervising Head of the Pharmacovigilance Therapeutic Unit Consumer Health

 

Your portfolio responsibilities & tasks:

  • Review of emerging safety data from various sources
  • Identify, validate, prioritize and analyze clinical safety signals timely ensuring appropriate safety risk communication and escalation within Bayer
  • Regular and ad hoc safety assessments
  • Creation of Benefit Risk Statements
  • Safety relevant communications such as DHCP letters and company statements
  • High quality answers to Health Authority requests
  • High quality aggregate reports (e.g. PSUR/PBRERs, RMPs) ensuring timely delivery
  • Ensure and justify adequate labeling of safety related information in the CCDS Working group, according to respective guidance/rules for drugs, nutritionals/food supplement
  • Communicating and partnering in a highly cross-functional work environment e.g. Medical /Regulatory Affairs, GCBU (business units), PQSC, Marketing, PV Alliance, Safety Committees (SRC,GSLQC), Legal and external experts /KOLs
  • Provide high quality input to new product developments including due diligences, clinical studies as well as  to life cycle management
  • Support preparation and maintenance of PV agreements

 

Who you are

  • MD degree or equivalent (e.g. PhD Pharm DO or MB) required.
  • Two years or more of clinical experience plus  several years of Pharma pharmacovigilance experience, or overall equivalent experience profile.
  • OTC knowledge /in particular knowledge on Nutritionals/food supplements preferred.
  • Competencies:
  • Incisive problem-solving skills for analysis of complex safety data; drawing conclusions and proposing solutions
  • Professional level written and spoken English
  • Excellent communication and presentation skills, both verbally and in writing
  • Negotiating skills in multifunctional and multinational teams is a core skill
  • Proven evidence of effective delivery /review of high quality safety relevant documents
  • Appropriate experience with Regulatory Agencies and KOL interactions
  • Good knowledge of pharmacovigilance relevant regulations
  • Experience in Global PV preferred (not mandatory)
  • Knowledge of relevant concepts in data management and systems, pharmacoepidemiology and statistics
  • Think and act strategically to put the grounds for strategic decision making

 

#Li-CH

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Country: Switzerland
Location: Basel
Functional Area: [sap_fa_30]
Entry Level: 5