• Job Description

  Req#: 795172

  At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

  Pharmacovigilance (PV) Senior Case Evaluator (MD) (f/m/d)

  YOUR TASKS AND RESPONSIBILITIES

  • Diligently evaluate and assess complex reports from clinical development projects as well as post marketing cases; reporting sources include medical literature as well as, clinical trials and post-marketing surveillance studies
  • Ensure medical plausibility, consistency and completeness of ADR case reports as well as request follow-up information, and initiate use of specific product/event-related questionnaires when necessary
  • Confirm determination of seriousness, assess drug product causal association and global labeling status (expected or unexpected) to achieve the appropriate case reporting status for global distribution for regulatory agency reporting
  • Provide medical/clinical advice for non-medic SCP colleagues and contribute to a continuous improvement of PV system and processes
  • Medically code various case data including all AE and drug term
  • Create written company causality comment for ADR case reports in accordance with internal standards and guidelines, including specific aggregate analyses and summary description of previous similar reports when required
  • Identify critical case reports that require immediate attention of the Global Safety Leader (GSL), including cases that are potentially suitable for extended discussion in PV aggregate reports (PBRER/ PSURs, DSUR and ASRs)
  • Participate in AE/SAE reporting compliance and quality analysis, when necessary and prepare and conduct trainings on case processing topics of interest

  WHO YOU ARE

  • MD degree, preferably with several years of clinical experience including 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
  • Basic 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) as well as basic knowledge of standard office software packages (Word, Excel)
  • 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 along with proactive behavior and the ability to keep timelines, drive results and manage complexity
  • Well established interpersonal, decision-making, and organizational skills, along with practiced training skills
  • The ability to establish cooperative working relationships with staff from different cultural and medical backgrounds
  • Fluency in English, both verbal and written

  YOUR APPLICATION

  This is your opportunity to tackle the world’s biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change. You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer.

  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.
  

  Location: Germany : North Rhine Westfalia : Wuppertal-Aprath

  Division: Pharmaceuticals

  Reference Code: 795172

• About the company

  Bayer AG is a German multinational pharmaceutical and life sciences company and one of the largest pharmaceutical companies in the world.

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