Global Pharmacovigilance Product Safety Coordinator

The role encompasses vigilance operations for Medicinal, Cosmetics (cosmetivigilance) and foods Supplement. The role is responsible for the implementation and management of a Global Pharmacovigilance System through Nelsons electronic QMS whereby;

  • The day to day operations are managed across all zones
  • The implementation of a Product Information database and the provision of medical and product information to Healthcare professionals/ consumers is done in a timely manner.
  • The co-ordination and management of all email correspondence through the customer support portal and the daily logging and follow up of all consumer complaints within the company Quality Management System (QMS). 

The primary function of this role is to implement and manage a global pharmacovigilance system including the creation of a Product Information Database. This will be managed through effective daily operation systems and will support the Qualified Person for Pharmacovigilance (QPPV) in maintaining and updating those systems. The individual is also responsible for providing medical, cosmetic and food information in response to queries from healthcare professionals, and for providing product information and advice to consumers. The role will review and log all consumer complaints which comes through the Customer Support Portal ensuring all timelines are met in relation to PV actions. KPI & trending analysis will be identified, and all reports logged within Nelsons QMS. The role also conducts vigilance operations for Nelsons Medicinal. Cosmetic and Nutritional products and supports the QPPV in developing and delivering vigilance training programs. 

 

Key Responsibilities

Customer Support

  • Manage the Customer Support Portal daily
  • Categorise all email correspondence 

 Customer Complaints Process

  • Logging of all customer complaints in accordance with company SOP/ Work Instructions through Nelsons electronic Quality Management System- Q-Pulse
  • Initial and follow up correspondence as per Nelsons SOP/ Work Instructions regarding Product Information and Consumer Review

Open, process all ICSR’s and follow up with Quality teams Closure

  • logging and trending of ICSR’s
  • Monthly, quarterly & annual reporting as required
  • Update and maintenance of PV database 

Adverse Drug Reactions - ADR’s

  • Open & process all ADR reports, including serious and suspected serious cases
  • Follow-up with Quality teams and company medic as required
  • Closure, logging and trending of ADR’s Reporting to Regulatory Authorities as required quarterly & annual reporting as required
  • Manage the quarterly ADR slides for the Quality Management Review Meeting 

Anonymised Single Patient Reports

  • ASPR’s -Review of all ASPR’s and escalation to QPPV as required
  • Logging and trending of ASPR’s 

 Literature Reviews

  • Review and record weekly literature reviews, escalating to QPPV as required
  • Report and trend ADR’s

Product Safety Review Meetings

  • Prepare and provide all data for Annual Safety Review Meetings
  • Review and approve minutes 

Medical & Consumer Information Requests

  • Respond to all medical information requests from:
  • Consumers
  • Healthcare professionals
  • Retailers
  • Internal requests 

Pharmacovigilance Systems Master File – PSMF

  • Bi-annual review of PSMF with the QPPV
  • Maintenance & Review of PSMF annexes with the QPPV 

 PV Standard Operating Procedures

  • SOP’s Review & update of PV SOPs with the QPPV
  • Implementation of new SOP’s as required
  • Review & implementation of Zone PV SOPs as required

 Pharmacovigilance Reports

  • Provision of PV data for Inspection and Annual PV Reports
  • Review and approval of PV Reports as required

 Safety Data Exchange Agreements –SDEA’s

  • Review & update of SDEA’s with the QPPV

Periodic Safety Update Reports - PSUR’s & PBRER’s

  • Provision of PV Data for PSUR’s & PBRER’s as required
  • Review and approval of PSUR’s & PBRER’s as required 

Food & Cosmetic Vigiliance Systems 

  • Open, process all ICR’s (individual Case Reports) & follow up with Quality
  • Closure, logging and trending of ICR’s
  • Monthly, quarterly & annual reporting as required
  • Authority reporting as required

 

Person Specification 

Essential 

  • Experience in using a computerised QMS
  • Life science or nutrition qualifications would also be desirable.
  • Team player with strong communication skills with the ability to communicate at all levels, internally and externally, with colleagues, consumers, patients and healthcare professionals.
  • The ability to be diplomatic, discreet and to maintain patient confidentiality.
  • Ability to plan, manage & execute projects in a timely manner.
  • Ability to prioritise and deal efficiently and effectively with workload.
  • Ability to work under pressure and maintain deadlines.
  • Flexible approach to work and tasks
  • Approachable and friendly
  • Confidence to challenge results and performance
  • Pro-active 

Desirable

  • Healthcare practitioner qualifications in CAM modalities and Bach Flower Practitioner training