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.
Senior Case Evaluator
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Senior Case Evaluator, are to:
- Diligent evaluation and assessment of complex reports from clinical development projects as well as post marketing cases;
- Report sources including medical literature as well as, clinical trials and post-marketing surveillance studies;
- Ensure high medical quality and compliance with all health authority requirements regarding adverse event / adverse drug reaction (AE/ADR) single case handling;
- Ensure medical plausibility, consistency and completeness of ADR case reports;
- 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) in order to achieve the appropriate case reporting status for global distribution for regulatory agency reporting;
- Provide medical/clinical advice for non-medic group members and medical coding of various case data including all AE and Drug terms which require in depth knowledge of the present coding systems (MedDRA and WHO-DD) with respect to structure and medical content;
- 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);
- Serve as mentor for pharmacovigilance (PV) Case Processors;
- Participate in AE/SAE reporting compliance analysis when necessary;
- Contribute to a continuous improvement of PV system and processes;
- Prepare and conduct trainings on case processing topics of interest.
WHO YOU ARE
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- PhD, PharmD, DPM, or DVM degree, MS, BS RPH, RN HCP or Life Science degree plus a minimum of 3 years of pharmacovigilance experience.
- Possess 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;
- Possess basic knowledge of International Council for Harmonisation (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;
- Possess good understanding of AE and drug coding conventions (MedDRA, WHO-DD);
- Basic knowledge of standard office software packages (Word, Excel);
- Excellent oral and written communication skills;
- Fluency in English (verbally and in writing) and be able to fluently communicate with colleagues from PV data entry sites in other countries;
- High sense of responsibility and accountability and special sense for diligence even for routine processes;
- Proactive behavior and ability to keep timelines;
- Possess well established interpersonal, decision-making and organizational skills, along with practiced training skills;
- Be able to identify problems in case evaluation and to assist in the design workable solutions;
- Possess or quickly develop the ability to establish cooperative working relationships with staff from different cultural and medical backgrounds;
- Drive results and manage complexity.
- MD with at least 2 years of clinical experience.
Relocation assistance offered.
State: New Jersey
Reference Code: 211363
Functional Area: Medical Affairs & Pharmacovigilance
Entry Level : Professional