Senior Specialist

5 months ago

Mumbai, India PharmaLex Full time

Your Job

To provide direct consulting and support for PharmaLex’s AB Cube SafetyEasy Hosted service, and to provide expertise in Pharmacovigilance and Safety Database systems in general. Provide consulting, training and support on client-facing and internal projects as it relates to the organization’s AB Cube SafetyEasy (safety database) Hosted service. Administer AB Cube SafetyEasy (Pharmacovigilance and Medical Information (MI) modules) – including with regards to database configuration and user account management. Provide first level support as part of the PV-IT Helpdesk. Perform data extracts and validation (QC) for analysis, archiving, migrations, etc. Migrate data into and out of AB Cube SafetyEasy. Perform PQ Testing in support of validation and upgrade of new releases. Train and mentor staff (PV and MI teams) on safety and medical information databases. Represent Pharmacovigilance department during for cause and maintenance client audits. Ensure compliance with internal standards and external regulations. Assist in developing and reviewing pertinent business area-related documents, procedures and working instructions (SOPs, WIs, and FAQs) in support of the Pharmacovigilance area, and ensuring that all activities are in adherence to such defined policies. Provide project management and oversight for both client implementation and PharmaLex internal projects. Any other responsibilities as discussed and agreed to with Supervisor, including any other Platform Technologies strategic initiatives.

Your Profile

At least 2-4 years of experience in the Life Sciences industry, with focus on pharmacovigilance. Bachelor of Pharmacy, or a comparable education. Experience in supporting and administrating Safety Databases, preferably AB Cube SafetyEasy. Good knowledge of computerised software validation (CSV), including GAMP 5 and 21 CFR Part 11. Experience working in GxP governed environments and environments controlled by Information Security Management Systems. Project management experience preferred. Strong communicator fluent in English. Highly organized with strong attention to detail and keen analytical skills – and the ability to efficiently multi-task and handle competing priorities. Ability to work enthusiastically and collaboratively as part of a cohesive group and also independently, as needed. Proactive approach to ensuring continuous improvement and growth for oneself, the Platform Technologies Team, and the PharmaLex organization.

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