Risk Management and Safety Surveillance PV Specialist
- Employer
- Planet Pharma
- Location
- UK
- Salary
- Competitive
- Closing date
- 15 Jun 2022
View more
- Sector
- Healthcare
- Contract Type
- Permanent
- Hours
- Full Time
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Key responsibilities for this role include:
The minimum qualifications for this role are:
- 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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