TASKS AND RESPONSIBILITIES

• Manage the group Global Drug Safety-Operations within a matrix organization, including resources and budget

• Supervise the Global Drug Safety-Operations staff, including respective prioritization, resource planning, recruiting, performance management, development, training

• Coordinate and manage the cross-functional processes for Adverse Event-handling (AE) to assure reporting of consistent high quality AE-reports in timely manner to authorities

• Monitor quality metrics; identify process improvements and coordinate and supervise related activities (e.g Corrective And Preventive Actions)

• Development and maintenance of Standard Operation Procedure/work instructions related to AE-handling

• Coordinate and supervise AE-reconciliation with regional and local Drug Safety functions

• Provide scientific advice to assessors and perform quality control and approval of AE-reports for assigned products, while ensuring timely processing and submission of high quality AE-reports to authorities or agencies

• Timely preparation of high quality aggregate safety reports (including Periodic Safety Update Reports) and Expert Statements for assigned products to assure timely submission to international authorities and to perform signal detection to demonstrate a continuous benefit-risk balance of these products

• Assure maintenance of product registrations for assigned products by appropriate safety risk management as chair of the assigned safety management teams preparing and approving risk mitigation measures, where appropriate, in support of the Qualified Person Responsible for Pharmacovigilance

• Represent Bayer Animal Health in national or international industry association to ensure company interests and to monitor future developments in pharmacovigilance

REQUIREMENTS

• University degree in veterinary medicine (e.g. DVM, PhD)

• Several years of relevant work experience in Pharmacovigilance (PV)/Drug Safety

among with extensive experience in pharmacovigilance processes

• Expertise in clinical development of veterinary medicinal products

• Profound knowledge of global PV legislation/regulation

• Management database, PV database and relevant computer software (MS Office) skills

• Open-minded and valuing diversity to be able to cooperate with people of different cultural background, understanding needs of different customers/organizations

• Strong leadership and organizational skills

• Excellent communicator (m/f) with outstanding negotiation skills and ability to educate and influence decisions

• Ability to structure complex issues, identify relationships among individual data in complex data pools, and reduce complexity

• Fluency in English, both written and spoken; an additional language is highly preferred