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.

Pharmacovigilance Systems Maintenance Scientist (m/f)

Your tasks and responsibilities

  • Responsibility to keep the computerized pharmacovigilance (PV) system operational and fit for purpose
  • Supervise the maintenance of all reference data (reference tables) used by the system and the regular reconciliation of this data with other sources (e.g. BRAIN, Impact, PV Agreements with license partners), especially for Chinese processes and regulations
  • Responsibility for maintaining the dictionary of all products and licenses including development products and licenses, with focus on China, including the maintenance of datasheets for Auto-labelling in cooperation with PV risk management and PV data analysis
  • Responsibility for maintaining the dictionary of all code lists, studies including non-company studies for which PV will have to process SAE reports (e.g. investigator led studies) - for every study the possible study treatments must be defined and maintained (before and after un-blinding if applicable) with focus on China
  • Responsible for the maintenance and support of a centralized PV reporting process for EudraVigilance (inbound & outbound via E2B), for all international health authorities, notified bodies and related license partners including the tracking of E2B acknowledgements for those reporting and CAPA handling in case of incompliant reporting especially to China
  • Maintenance of case distribution matrix including the list of all reporting destinations as well as the reporting rules per product and recipients (PV country heads through affiliate module, external partners, study teams, etc.)
  • Drive, create and maintain case save procedures, data quality checks with health authorities and license partners world wide with special focus on China
  • Leads and maintains required PV systems changes, incl. preparation and execution of change controls (like IQ,OQ,PQ), especially concentrating on Chinese PV processes

 

Who you are

  • PhD, PharmD, DPM, or DVM degree or MS, BS RPH, RN HCP, or Life Science degree or master degree in medical documentation in medicine and information technology with several years of pharmacovigilance experience or clinical experience or relevant Bayer Pharmaceuticals AG experience
  •  Degree in computer science with experience pharmacovigilance or related functions preferred

  • Good knowledge of a PV product dictionary and related data

  • Profound knowledge of global regulations and guidelines

  • Detailed  experiences and expertise in the maintenance of a globally operated system for Pharmacovigilance

  • Substantial experience with project management in an intercultural context, especially China

  • Excellent oral and written communication skills in English and Chinese

 

 

 

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: 29633