PV (Pharmacovigilance) Case Evaluator

Major 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. 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 assign global labeling status (expected or unexpected) in order to achieve the appropriate case reporting status for Global distribution for Regulatory Agency reporting.
• Confirm (medical) coding of various case data including all AE and Drug terms.
• This requires 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.
• Identify critical case reports that require immediate attention of the GSL (Global Safety Leader).
• Pre-select cases that are potentially suitable for extended discussion in PV aggregate reports (PSURs and ASRs).
• Serve as mentor for PV Case Processors
• Participate in AE/SAE reporting compliance analysis, when necessary.
• Contribute to a continuous improvement of PV system and processes

Requirement

• MD degree (preferably with 2 or more years of clinical experience); or PhD, PharmD, DPM, or DVM degree, MS, BS RPH, RN HCP or Life Science degree plus at least 3 or more years of pharmacovigilance experience.
• Must possess good medical/clinical interpretation skills based on potentially limited information provided along with a comprehensive understanding of medical terminology.
• Should have or quickly develop 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.
• Should have or quickly develop 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 are essential.
• Fluency in English is essential (verbally and in writing). Must 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
• Should possess well established interpersonal, decision-making, and organizational skills, along with practiced training skills.
• Ability to identify problems in case evaluation and to assist in the design workable solutions