Signal Detection and Evaluation
Drives routine signal detection process, including review of individual case reports via Case Awareness Tool, literature review, On-Line Signal Management Tool - for products under team responsibility.
Leads the assessment of safety data, discusses priority of review of safety related findings/ signals with scientists, SERM Team Leader/ SERM physician. Provides strategic input into signal detection process.
Drives use of appropriate sources of information and database searches to retrieve relevant data for explorations/ evaluation of signals.
Analyses safety data and discusses the results with the SERM Team Leader/ SERM physician and other key
stakeholders, as appropriate. Produces accurate and fit for purpose exploratory/ evaluation documents, in response to internal or regulatory authority requests for safety data.
Provides oversight over routine monitoring of safety issues potentially related to a product defect and/or manufacturing issue; communicates with the SERM physician/ SERM Team Leader and/or Manufacturing; ensures documentation of outcome.
Aggregate Reports and other Regulatory Submissions
Authors/ Provides oversight over authoring of periodic regulatory documents (PBRERs) according to the agreed process and timelines.
Provides oversight over production of license renewal documentation (e.g. Addendum Reports, Line listings, Clinical Overviews), requested by Local Operating Companies.
Coordinates compilation of SERM safety contribution to global regulatory submissions or answers to safety-related questions from Regulatory Agencies. Provides strategic guidance for less experienced personnel.
Risk Management activities
Authors/ Provides oversight over production of global Risk Management Plans/ regional Risk Management Plans for designated products.
Provides strategic contribution to Regulatory Benefit-Risk Assessments requiring safety team input.
Provides input on cross-functional ad-hoc teams set up to address urgent and important safety issues.
Supervises creation and maintenance of Non-Central Data Sheets (NCDS) (the Global Product Information (PI) for non-GSK originated products), in line with Reference Product Information and other relevant reference sources. Cooperates strategically with relevant functional experts.
Provides oversight over regulatory supporting documentation for labelling updates.
Provides oversight over labelling changes recommended for European Single Market Products.
Provides strategic guidance for response to Regulatory Enquiries related to labelling content.
Provides strategic input into regulatory requests for local label deviations from the NCDS content (Country Labelling Difference Process).
Other SERM Activities
Provides strategic input into reviews of Safety Data Exchange Agreements, and escalates any deficiencies to the SERM Director to ensure quality and integrity of agreement. May advise on the preparation of licensing agreements in the area of responsibility.
Provides oversight over communication with licensing partners.
May assist in due diligence activities in collaboration with senior stakeholders.
May provide support to GSK Legal, as appropriate.
Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
Participates in, and may lead, a process improvement initiative team within Central Safety Department. May contribute to advancement of methodology and process by generating new ideas and proposals for implementation.
Raises concerns/ issues to senior management in a timely, open and appropriate manner; ensures quality and integrity of issue/event being escalated.
Conducts Management Monitoring and ensures quality of the processes under team responsibility.
Defines and manages Key Performance Indicators (KPIs).
Trains and mentors scientists in the scientific aspects of signal evaluation methodology and risk management and preparation of safety reports and other documents, as well as supports personal development.