To actively manage and evaluate risks associated with assigned vaccine projects, and make recommendations for the management and communication of risks in accordance with global legal and regulatory frameworks. This will involve working in partnership with the VCSP Safety Scientist to deliver the following:
- Coordinate and perform the medical analysis of adverse event reports and/or signal detection activities for assigned vaccine projects in clinical development and post-licensure
- Be the safety contact person for Clinical, Regulatory Affairs, regional and LOC (local operating company) safety managers, manufacturing teams for assigned vaccine projects
- Provide medical input to Clinical Teams with respect to safety aspects of the design and preparation of protocols, investigators brochures, investigator letters and reports, for the follow up and processing of clinical study data and lead the safety analyses of the assigned projects.
- Ensure creation, maintenance and implementation of (D)CSI (Development, Core Safety Information) for the assigned projects.
- Ensure provision of the Benefit Risk Assessment and risk identification, assessment and mitigation activities for assigned vaccine projects
- Perform medical review and provide medical advice on safety-related aspects associated with the assigned vaccines.
- Perform signal detection and evaluation of safety for assigned projects.
- Manage the evolving safety profile of assigned vaccine projects during clinical development and lifecycle management
- Provide appropriate and timely Benefit Risk Assessments and safety related regulatory reports for assigned vaccine projects
- Design, track and follow up risk management plans for the products assigned and assure their sound implementation.
- Lead the Safety Review Team and be a project team member for assigned vaccine projects
- Develop and revise assigned central pharmacovigilance processes and related training.
- Answer and follow-up enquiries from regulatory authorities and other bodies (e.g., Ethics Committees) regarding safety-related aspects.
- Implement of applicable regulations for the assigned vaccines.
- Participate in IDMC meetings or other safety related interactions with outside collaborators of the assigned vaccine projects.
- Implement and follow-up of safety data exchange agreements for products assigned.
Why You? Basic Qualifications :
- Ability to make independent clinical assessments and decisions, based on professional and scientific responsibilities to patients, prescribers, regulators, and providers.
- Ability to analyze large datasets and lead multidisciplinary teams to provide accurate and robust assessments of such safety-related data.
- Providing scientifically based safety assessments within complex public environment.
- Lead cross-functional interactions within GSK Vaccines, such as clinical, regulatory affairs, biostatistics, data management, manufacturing and legal.
- Provide external reference for any safety-related request from local authorities and participate in external meetings with regulatory agencies or present.
We are looking for professionals with these required skills to achieve our goals: Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- 2-3 years Post-Residency Clinical Practice Experience
- Preferred expertise in Infectious Diseases, Pediatrics, Epidemiology or Vaccines
- Previous experience in the Pharmaceutical or Biotech industry working in Clinical Development, Medical Affairs, Pharmacovigilance, Drug Safety or a related field.
- Knowledge of Pharmacovigilance and signal detection tools, analysis and reporting of medical safety issues for vaccines, taking into account the worldwide regulatory requirements.
- Knowledge and experience in collection and interpretation of Serious Adverse Events case reports.
- In depth understanding of the regulatory environment (e.g. International, US and European Legislation).
- Ability to apply sound medical judgment in interpretation of safety-related data.
- Able to prioritise activities effectively and to meet multiple deadlines successfully with attention to detail, setting high performance standards for quality
- Ability to manage crises, monitor safety issues and work under pressure with a customer and solution oriented approach.
- Demonstrate initiative and creativity in performing task and responsibilities. Proactively contributes ideas to improve existing operations
- Excellent mastery of English, written and spoken with strong communication and influencing skills.
- Integrity and strong feeling for ethics.
- Computer literate, familiar with using scientific and clinical databases.
- Good administrative skills, analytical mind.
- Strong leadership and collaborative working skills
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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