PV (Pharmacovigilance) Case Processor

Major Responsibilities：

• Promptly and accurately identify, interpret and enter adverse event and all relevant corresponding case information into the global database for serious and non-serious AE/ADR case reports. This must be done in accordance with internal data entry standards and within specific timelines as prescribed by global regulations and SOPs.
• Verify, as prescribed by regulatory guidelines, that trade names are correctly translated into INN (International Non-proprietary Name).
• Perform accurate coding of incoming serious and non-serious adverse events and other case information using MedDRA terminology.
• Perform assessment of cases regarding the global listedness
• Create comprehensive case narratives based on all relevant, related information received from local affiliate and/or from various source documents .
• Determine drug-event relationship in non-serious ADR/AE case reports.
• Request additional follow up information from local affiliate for the completion of case reports.
• Contribute to a continuous improvement of PV system and processes.

Requirement：

• MD degree (with no or little clinical experience), or, Pharmacist, Veterinarian, Biologist, Nurse, HCP Life Science degree, or similar education with medical or scientific focus.
• Fluency in English (verbally and in writing). Must be able to fluently communicate with colleagues from PV data entry sites in other countries.
• Should be willing and able to quickly develop in-depth understanding of database field structure, and processing rules.
• 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)
• High sense of responsibility and accountability and special sense for diligence even for routine processes
• Proactive behavior and ability to keep timelines
• Well established interpersonal skills. Excellent oral and written communication skills are essential
• Must possess good medical/clinical interpretation skills based on potentially limited information provided along with a comprehensive understanding of medical terminology.
• Should possess well established interpersonal, decision-making, and organizational skills, along with practiced training skills