Expert Case Evaluator - Wuppertal, Deutschland - Bayer

Bayer

Geprüftes Unternehmen

Wuppertal, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

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.

Expert Case Evaluator (M/F/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 high medical quality and compliance with all health authority requirements regarding AE/ADR single case handling as well as medical plausibility, consistency and completeness of ADR case reports
Confirm determination of seriousness, assess drug product causal association and assign 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 nonmedic SCP colleagues and contribute to continuous improvement of PV system and processes
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
Serve as mentor (M/F/d) for PV Case Processors and new PV Case Evaluators and be medical advisor (M/F/d) for the accuracy of case assessment and company causality comments of peers (CE colleagues)
Participate in AE/ADR reporting compliance analysis when necessary and conduct trainings on case processing topics of interest
Be representative (M/F/d) for inspection activities as requested and act as contact person for Risk Management function as nominated within the TA

WHO YOU ARE

MD degree combined with preferably several years of clinical experience as well as longterm working experience in pharmacovigilance or other relevant 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 understanding of local and global regulatory rules and regulations as well as knowledge of safety policies and procedures in the major countries
Good understanding of AE and drug coding conventions (MedDRA, WHO-DD) as well as ability to collect, interpret and analyze data from internal and external databases (e.g. Argus, Incidence & Prevalence Database, FDA AERs etc.)
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 of workable solutions while driving results and managing complexity
Ability to establish cooperative working relationships with staff from different cultural and medical backgrounds
Fluent in English, both written and spoken

LI-DE

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.

Location:
Wuppertal-Aprath

Division:
Pharmaceuticals

Reference Code:796290