Job description Posted 20 June 2022

Senior Scientist (Safety Data Exchange Agreements)

12 Months

ASAP Start

£300-£350p/d via approved Umbrella

This role is responsible for co-ordination, end to end evaluation, negotiation, and delivery of Safety Data Exchange Agreements (SDEAs) with Licensing Partners to ensure GSK can meet its drug safety and vigilance obligations and ensure Patient Safety.

This role owns GSK Standard Operating Processes (SOPs) for SDEAs worldwide.

This role is responsible for leading internal projects relevant to SDEAs, change management and making significant contributions to enable or improve compliance with global regulatory requirements for drug safety and vigilance.



  • Manage end to end SDEA activities with business partners. These activities include without limitation:
  • Acts as the primary Third-Party collaboration contact on all matters relating to SDEAs for internal and external stakeholders
  • Performs due diligence of Third Parties’ vigilance systems prior to SDEA negotiation
  • Initiates, negotiates and revises SDEAs as required
  • Ensures compliance with worldwide PV, materiovigilance and cosmetovigilance regulations, guidelines and industry practice
  • Applies standardised contract guidelines in line with company polices and legal and regulatory constraints
  • Conducts routine reviews of SDEAs to ensure adherence with global requirements, GSK business practices and the terms/status of the commercial agreement
  • Trains internal and external stakeholders, as required, to ensure understanding of the terms of the SDEAs
  • Works closely with relevant function across company including business development, legal departments, Quality, Medical Affairs to review and approve PV term in commercial agreements where needed
  • Coordinates divestment activities, such as:
  • Reverse due diligence and safety data preparation in collaboration with stakeholders from other safety departments
  • implementation of separation activities related to safety data, e.g. safety database transfer to licensing partners
  • Oversees compliance monitoring of SDEAs
  • Supports Local Operating Companies (LOC) on local SDEAs
  • Oversees the maintenance of the Pharmacovigilance Agreements (PVA) database, SDE website and other storage locations
  • Runs standard listings from relevant safety and PVA databases, as required

Inspection/Audit Support

  • Acts as a contact point for audits, partner assessments and inspections
  • Implements problem solving strategies across SDEA teams, such as root cause analysis and CAPA development



  • Prepares, coordinates and delivers SDEA process training to relevant staff across company including LOCs, external PV vendors, legal departments and Business Development


Process/Policy Support

  • Develops and maintains process documents defining the responsibilities of GSK staff for due diligence of vigilance systems and negotiation and implementation of SDEAs
  • Develops and maintains Global SDEA templates
  • Keep up to date on regulatory/legislation changes and implement changes in SDEAs and SDEA processes/template when applicable
  • Responds to queries on strategy/policy related decisions associated with SOPs/guidance documents
  • Identifies risks to SDEA processes/groups and implements mitigation strategies
  • Maintains knowledge and compliance of GSK’s processes and systems
  • Manages multiple complex projects relevant to SDEAs


  • Manages staff and oversee direct reports’ work


  • Bachelor’s Degree in life sciences or equivalent
  • Minimum 5 years of experience in Pharmacovigilance or equivalent
  • Experience working with teams and individuals in other parts of the business in a collaborative manner to develop business solutions and create value
  • Proven project management skills and change management experience
  • Proven experience of SDEA, Pharmacovigilance, regulatory and business requirements
  • Experience of internal and/or external audits and inspections