Scientific Director
3 weeks ago
At GlaxoSmithKline, we're committed to uniting science, technology, and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty, and general medicines.
Job DescriptionThis position supports 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.
Key Responsibilities:- 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.
- Demonstrated track record of quality decision making and creative problem resolution, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context.
- Leads safety governance by development of safety strategy and its execution for products in clinical development and post marketing settings.
- Facilitates safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues.
- Leads presentations on recommendations or safety issues to senior staff members at the GSK Senior Governance Committees.
- Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D, Dentists and Veterinarians are also accepted).
- Experience in the Pharmaceutical or Biotech industry working in Drug Safety or Pharmacovigilance.
Estimated salary: £90,000 - £110,000 per year.
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