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This position supports, for example, one or more of the following Therapeutic Areas: Respiratory, Infectious Diseases/HIV, Hepatitis/Fibrosis, Neurology/Dementias. Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets or in clinical development and/or the post-marketing setting. Ensures scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. Makes recommendations for the further characterization, management, and communication of safety risks. Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs. Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.
Job Responsibility:
Leads Pharmacovigilance and Risk Management Planning and develops strategy for approach to evaluation of issues in the clinical matrix
Leads the safety component of global regulatory submissions
Expert evaluation skills and analytical thinking for literature review, clinical data synthesis, analysis and interpretation
Leads safety governance by development of safety strategy and its execution for products in clinical development and post marketing settings
Represents GS on cross-functional Clinical Matrix Teams and/or Project Teams
Leads or participates in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality and efficiency
Authors/participates in written standard updates (e.g., SOPs)
Accountable for the escalation of issues and communication on safety matters
Leads presentations on recommendations or safety issues to senior staff members at the GSK Senior Governance Committees
Leads cross-functional process improvement team within GSK
Leads inspection readiness and prepared as needed to support audits/inspections
Requirements:
PhamD/PhD for Scientist (preferred), Bachelors of Science in Life Sciences or Medical Sciences (minimum standard)
Advanced experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance, or Drug Safety
Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities
Experience with Signal Detection and safety surveillance
Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes