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Medical Doctor as Senior Case Evaluator (m/f)

Bayer is a global enterprise with core competencies in the fields of health care,
agriculture and high-tech polymer materials. As an innovation company, it sets trends
in research-intensive areas. Bayer’s products and services are designed to benefit
people and improve their quality of life. Bayer HealthCare combines the global
activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals
divisions. Its aim is to discover, develop, manufacture and market products that will
improve human and animal health worldwide. 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.

Senior Case Evaluator (m/f)

YOUR TASKS AND RESPONSIBILITIES

  • Responsibility for the medical evaluation of AE/ADR case reports from spontaneous reporting sources including medical literature as well as from clinical trials and post marketing surveillance studies to ensure high medical quality and compliance with all health authority requirements regarding AE/ADR single case handling
  • Ensure medical plausibility, consistency and completeness of ADR case reports
  • Provide medical/clinical advice for non-medic group members
  • Confirm determination of seriousness, assess drug product causal association and assign global labeling status in order to achieve the appropriate case reporting status for global distribution for regulatory agency reporting
  • Medical coding of various case data including all AE and Drug terms
  • Create written company causality comment for ADR case reports in accordance with internal standards and guidelines
  • Identify critical case reports that require immediate attention of the Global Safety Leader (GSL) and pre-select cases that are potentially suitable for extended discussion in PV aggregate reports (PBRERs and ASRs)
  • Serve as mentor (m/f) for PV Case Processors
  • Participate in AE/SAE reporting compliance analysis, when necessary
  • Contribute to a continuous improvement of PV system and processes

WHO YOU ARE

  • MD degree, preferably with several years of clinical experience
  • Good medical/clinical interpretation skills based on potentially limited information provided along with a comprehensive understanding of medical terminology and proven capabilities in differential diagnosis
  • Knowledge of ICH principles of SAE/AE reporting along with basic understanding of local and global regulatory rules and regulations and basic knowledge of safety policies and procedures in the major countries
  • Good understanding of AE and drug coding conventions (MedDRA, WHO-DD)
  • High sense of responsibility and accountability and special sense for diligence even for routine processes
  • Ability to identify problems in case evaluation and to assist in the design workable solutions
  • Proactive behavior and ability to keep timelines
  • Should possess well established interpersonal, decision-making, and organizational skills, along with practiced training skills
  • Excellent oral and written communication skills
  • Business fluent in English, both written and spoken
YOUR APPLICATION
We offer a competitive salary in an international environment as well as excellent
opportunities for professional and personal development. If your background and personal
experience fits this profile, please send us your complete application at www.career.bayer.de,
submitting a cover letter, your CV and references as well as your salary expectation.
Country
Germany
Location
Wuppertal Elberfeld
Division
Bayer HealthCare
Contact us
Phone +49 214 30 99779
www.career.bayer.de
Reference Code
0000131618
Bayer welcomes applications from all
individuals, regardless of racial or
ethnic origin, skin color, nationality,
religion, philosophy, gender, age,
disability, appearance or sexual
identity. We are committed to treating
all applicants fairly and avoiding
discrimination.
Bitte beziehen Sie sich bei Ihrer Bewerbung auf jobvector und geben Sie die folgende Referenznummer an: 0000131618