Pharmacovigilance Services Associate
Designation: Pharmacovigilance Services Associate
Qualifications:Any Graduation/Bachelor Degree in Life Sciences
Years of Experience:1 to 3 years
Language - Ability:Japanese - Elementary
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What would you do? Overall Purpose of the Job o To process (translate and data entry) individual case safety reports (ICSR) according to the client relevant global procedure on case intake processes. To perform case processing and reporting for Japan foreign cases. Also to perform quality review/submissions as needed as per the business requirement.
What are we looking for? Educational, Experience and skill Requirements o Any Degree/associate degree, Life sciences, medical, pharmacy or related department preferred and not mandatory o Life science industry experience preferred and not mandatory o Good English verbal and writing skills. o Japanese Japanese-Language Proficiency Test – JLPT/equivalent certification- Minimum N5 above o Self-motivated and enthusiastic. o Detail oriented
Roles and Responsibilities: •Responsibilities/Authorities o Translate case information from local language to English (name, age etc.) if applicable o Data entry of the relevant information into the client platform in English o Conduct translations with accuracy if applicable o The data entered should reflect the information in the source documents o Fill up the Japan specified requirement according to Japan regulation in Japanese o For Japan HA reportable cases, prepare Japan HA E2B reports o Monitor ACK in submission review workflow as required o Perform internal case quality control to assess and ensure correct information provided in intake, literature, follow up and case processing and reporting for Japan foreign cases o Perform case corrections according to the errors identified by client. Proactively participate in RCA (Root Cause Analysis) and CAPA creation and implementation. Complete trainings for individual performance improvement o Understand and abide deadlines without compromising on quality o Plan and organize work so that SLAs are not missed o Ensure Quality standards are met as laid out by the client and Accenture o Ensure compliance with Business policies and contractual requirements of Accenture o Demonstrate the ability to work as a part of the team o Seek advice and escalate issues when facing tasks or problems outside the normal scope of the job o Adaptable to learn new processes, concepts and skills o Flexible to work in shift as per business requirements.
Bengaluru
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