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Risk Management and Safety Surveillance PV Specialist

Planet Pharma
Closing date
15 Jun 2022

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Contract Type
Full Time
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Key responsibilities for this role include:
  • Aggregate Reports related activities
  • PSUR and ACO scheduling, writing & submission
  • Line Listing (LL) and Summary Tabulation QC
  • Handling of requests received from Central & Local Regulatory Affairs and PV departments with respect of timelines
  • Conducting Safety reviews
  • Conducting risk-benefit analysis
  • Risk Management Plans
  • Author RMPs and RMM effectiveness reports
  • Author educational materials and support with additional risk minimization activities as assigned
  • Assist in any other activities related to RMP process
  • Signal Management
  • Author signal detection reports and participate in review of eRMRs
  • Author signal validation and assessment reports
  • Assist in any other activities related to signaling process
  • Safety Trigger Monitoring:
  • Review of various Health Authority websites for safety triggers and taking appropriate actions including but not limited to:
  • raising and/or supervising staff raising TW change controls;
  • communication of the new safety updates and other safety related label changes
  • updating the tracker and archiving the relevant documents in the HA folder
  • SPC/PIL review in accordance with internal guidelines and provide them for QC and submit to regulatory
  • Company Core Data Sheet (CCDS)/ Reference Safety Information:
  • Safety related contribution in CCDS/RSI development, review and updating
  • Responsible / assisting in maintenance of CCDS/RSI database
  • Health Authority Responses
  • Responsible / assist in preparation of responses to Regulatory Authority questions related to safety issues within respect of timelines
  • Developing responses to HAs and ensuring correct, information is sent to the HAs, within the required timelines.
  • Keeping oversight of assigned mailbox through triage and archival of emails for SST.
  • Liaise with internal and external stakeholders and Viatris drug safety in performance of the above-mentioned tasks.
  • Assist in any other Pharmacovigilance projects such as SST Quality Management Systems, Clinical Overview Addendum(s) and Biosimilar related project activities, as assigned
  • Keep current with professional and pharmacovigilance regulations and knowledge

The minimum qualifications for this role are:
  • Graduate or postgraduate in pharmacy/health sciences
  • Significant experience in pharmaceutical industry working within pharmacovigilance specifically with risk management and safety surveillance.
  • Excellent time management skills and must be able to work to tight timelines.
  • Ability to manage own workload and interact well in a team environment
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