Pharmacovigilence and Safety Associate-No experience required, Work from home

Planet Pharma

Job Description

No experience required. Entry Level, Work form home opportunity with a leading vaccine manufacturer. Training will be provided.


Key Accountabilities and Qualifications

  • Life Sciences Degree preferred (Pharmacy, Medicine, Biology, Chemical Engineering etc.) or related working experience
  • Good knowledge of Pharmacovigilance is an advantage
  • knowledge of MS Office (Word, PowerPoint, Excel)
  • Excellent interpersonal, verbal and written communication skills
  • Ability to plan, organize, prioritize, and execute multiple tasks within assigned objectives
  • Ability to work effectively in an international matrix team and value the importance of teamwork




Job Requirements

  • Completes drug safety monitoring and tracking in a timely, thorough and accurate manner in accordance with
  • pharmacovigilance (PV) and related standards, regulations and Standard Operating Procedures(SOPs)
  • Reviews, evaluates and verifies potential AE information during Preliminary Assessment (PA) to determine required action per internal policies and procedures and perform data entry of adverse event by timely completion of the case via Roche global safety database. Performs seriousness / validity / causality and conducts quality review of all cases (as applicable) based on their medical assessment
  • Performs labelling assessment for AE(s) received using clinical knowledge and conducts follow up for all reported cases (as applicable)

    Responsible for Clinical Review of cases processed in-house and by vendors

  • Performs trend analysis of vendor case processing issues and escalates to vendor and USDS management
  • Responsible for developing executive summary on the quality trends observed o n a quarterly basis
  • Manage and process all SAEs as per project specific instructions
  • Document Control: maintain electronic files for department, perform file case searches, maintain file room for the department and use department databases to track, manage and control issued documents; assign various tracking numbers
  • Track and process assigned pharmaceutical and Data Management Center (DMC) queries
  • Assist in the preparation of contract-required reports
  • Generate specified data reports from the safety database as requested
  • Process and edit safety narratives for IND and Non-IND Adverse Event (AE) cases as required
  • Distribute Safety Information according to project specific requirements
  • Assist in processing of MedDRA coding tasks

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