Global Pharmaceutical Company
Pharmacovigilance Case Processor
Is responsible for full global data entry of Adverse Effects (AE) /Adverse Drug Reaction (ADR) case reports from various sources into the Global Pharmacovigilance database. This includes entry of all relevant case information into structured database fields in accordance with internal case processing standards, the coding data; ensure completeness and consistency of all data entry fields in order to have a proper case narrative
- Promptly and accurately identify, interpret and extract adverse event and all relevant corresponding case information from a wide variety of source documents.
- Enter the extracted information into the global database for serious and non-serious Adverse Effects /Adverse Drug Reaction case reports.
- Identify information such as product technical complaints in the source documents, which must be further processed by the local affiliate, and forward accordingly
- Adhere to internal data entry standards and specific timelines as prescribed by global regulations and SOPs.
- Create and review comprehensive medical case narratives with no important gaps regarding the reported information received.
- 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
- Enter drug-event relationship in non-serious and serious expected ADR/AE case reports as per company policies.
- Ensure medical plausibility, consistency and completeness of ADR case reports and appropriate case level status with regard to regulatory agency reporting.
- Request follow-up information for the completion of case reports, making use of specific product/event-related questionnaires when necessary. Consult medical experts within TA group for advice in clinical questions.
- Contribute to a continuous improvement of PV system and processes.
- Receive instruction, support and guidance from more experienced colleagues (CP/CE)
- University degree in science, biology etc.)
- over 2 years work experience in Pharmacovigilance (Drug Safety)functions preferable
- 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).
- Must possess good medical/clinical interpretation skills based on potentially limited information provided along with a comprehensive understanding of medical terminology.
- Fluency in English TOEIC 800 and above (verbally and in writing) and Native Japanese. Must be able to fluently communicate with colleagues from PV data entry sites in other countries.
- 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
- Should possess well established decision-making and organizational skills, along with practiced training skills.
- Should possess or quickly develop the ability to establish cooperative working relationships with staff from different cultural and medical backgrounds
(Experiences and skills will be considered)
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.