Overview
This position supports the HIV Therapeutic Area. The role is responsible to:
Responsibilities
* Provide in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting.
* Ensure scientifically sound review and interpretation of data and management of safety issues and escalate safety issues identified through the safety review process to senior management and safety governance as appropriate. Make 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. Support pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.
* Lead the safety components of global regulatory submissions (e.g., Module 2.7.4, ISS, RMPs, safety sections of labeling documents).
* Lead Pharmacovigilance and Risk Management Planning and develop strategy for evaluation of issues in the clinical matrix.
* Demonstrate expert evaluation skills and analytical thinking for literature reviews, clinical data synthesis, analysis and interpretation.
* Display a 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.
* Demonstrate highly developed multi-tasking skills, ability to prioritise tasks and consistently deliver on deadlines with high quality standards.
* Explore positions and alternatives to reach mutually beneficial agreements and solutions.
* Lead safety governance by developing safety strategy and its execution for products in clinical development and post-marketing settings; anticipate, detect and address product safety issues and ensure risk-reduction strategies are implemented appropriately.
* Facilitate safety governance/Safety Review Teams in clinical development and post-marketing settings by establishing and operating cross-functional teams to detect and address product safety issues and ensure risk-reduction strategies are implemented in clinical study protocols and/or product labeling.
* Represent Global Safety on cross-functional Clinical Matrix Teams and/or Project Teams; lead cross-functional ad hoc teams to address urgent and important product safety issues.
* Lead or participate in cross-functional process initiatives and/or Process Workstreams to drive adherence to regulations, data standards, quality and efficiency.
* Author/participate in written standard updates (e.g., SOPs) to ensure policies and regulations are adhered to correctly and consistently.
* Escalate issues and communicate safety matters to senior management and governance committees.
* Build strong working relationships and demonstrate leadership on safety issues within a matrix team; able to coach and mentor others.
* Communications (verbal, written) and Influencing (internal PV Governance and External LTs): Lead presentations on recommendations or safety issues to senior staff at GSK Senior Governance Committees and interact confidently with regulatory authorities, external consultants, and licensing partners as appropriate.
* Lead cross-functional process improvement efforts within GSK; contribute to long-term safety strategy for clinical programs and drive innovations to address new issues or improve operations.
* Lead inspection readiness and be prepared to support audits/inspections.
Qualifications
* Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D; dentists and veterinarians also accepted). Advanced degree preferred.
* 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/approval processes.
* Experience working in large matrix organizations.
* Prior experience in the HIV therapy area and with global regulatory submissions is desirable but not essential.
Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company focused on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases. We are an Equal Opportunity Employer and ensure that all qualified applicants receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law. We support an agile working culture and encourage discussion with our hiring team about flexible opportunities.
Note: If you are a US Licensed Healthcare Professional, GSK may be required to capture and report expenses on your behalf if you are afforded an interview for employment, to ensure compliance with federal and state US Transparency requirements. For more information, visit the CMS Open Payments data website.
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