Parexel Pharma Drug Safety Specialist Vacancy 2021 – Apply Online
Parexel Drug Safety Specialist vacancy 2021. Parexel invites postgraduate candidates with degrees in pharmacy. Pharma job opening 2021. Pharma job in Parexel. Check out all the details on the same below:
Job Title: Drug Safety Specialist
Job ID 74456BR
Location: Mohali, Punjab, India
Eligibility Criteria:
Health Professional (Masters in Pharmacy)
- Work with Web-based applications and familiarity with Windows Operating System and MS office suite (Word/Excel/PowerPoint)
- Capability to make concise, accurate, and relevant synopsis of medical text and data, and the ability to write unambiguous medical text.
General
Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, and SOPs, and Global drug safety regulations
• Maintaining an awareness of global regulatory reporting obligations and organizing work to ensure compliance with internal and regulatory timelines for the adverse event reporting
• Assist in the development of project-specific safety procedures, workflows, and templates.
• Attend/Conduct internal, drug safety and project-specific training sessions
• Completes training assigned on internal and client Learning Management systems (LMS) as applicable
• preparation for, participation in, and follow up on audits and inspections
• Maintaining an awareness of
the performance metrics measured by the client and striving to remain within established limits• Delegate work as appropriate to Drug Safety Assistants
• Liaising and collaborating with the relevant function at the client’s end to facilitate the delivery of high-quality work
• Identifies areas of concern and raising the issues with senior management
• Assist with additional Drug Safety Specialist and/or senior management in project-related activities as required
• Mentoring new recruits in the team, if required
• Archiving the source documents and relevant emails as required
Case Processing
• Monitoring of incoming reports from various sources viz mailboxes, Eudravigilance, literature searches, etc.
• Triage of incoming reports for completeness, legibility, and validity, including literature abstracts/articles/citations
• Perform a check on overall medical cohesiveness and consistency of the document
• Compares and analyses data provided by the affiliate with the data available on the client application
• Addition of new products/deletion of products withdrawn from the market/expired license/MAH transferred products on the client application tool
• Creates the case on the safety database and performs Data entry into safety database
• Performs clear and accurate data capture of cases in accordance with client conventions/guidelines and Standard Operating Procedures (SOPs)
• Ensures that the expectedness, causality assessment and seriousness criteria are accurate for the events
• Ensures MedDRA coding in accordance with “MedDRA Term selection: Points to Consider”
• Request follow-up and perform query management, as applicable
• Prepares medically cohesive case narratives based upon the reported information
• Routes the case to the next workflow state as applicable in the safety database
• Performs quality checks/validation checks
• Perform literature searches as per search strategy, performs data entry of valid cases into the safety database
• Case reconciliation- coordinating activities with Data Management
• personnel
• Line listing and tabulation generation for safety reports i.e. periodic safety reports, ad hoc safety reports, etc.
Drug safety Reporting
• Quality control of case reports, line listings, and tabulations
• Develop Expedited Reporting Procedures
• Maintain local drug safety reporting requirements
• Perform registration with relevant authorities for electronic reporting on behalf of the sponsor
• Perform setup and deployment of worldwide reporting as required to
regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy)
• Submission of safety reports to investigators via ISIS (International Safety Information System)
• Tracking and filing of submission cases as require
Editors Note: Parexel Pharma Drug Safety Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
