Safety Physician
il y a 1 semaine
Site Name:
Belgium-Wavre
Posted Date:
Feb
Are you looking for a pharmacovigilance role that allows you to actively manage and evaluate risks associated with assigned vaccine projects, as well as making recommendations for the management and communication of risks in accordance with global legal and regulatory frameworks? If so, this Safety Physician role could be an ideal opportunity to explore.
This role will provide YOU the opportunity to lead key activities to progress YOUR career.
These responsibilities include some of 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 postlicensure
- 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 safetyrelated aspects associated with the assigned vaccines.
- Signal detection and evaluation of safety for assigned projects.
- Manage the evolving safety profile of assigned vaccine projects
- Provide appropriate and timely Benefit Risk Assessments for assigned vaccine projects
- Design, tracking and follow up of risk management plans for the products assigned and assure their sound implementation.
- Lead the Safety Review Team and be VLT (Vaccine Leadership Team) member for assigned vaccine projects
- Develop and revise of assigned central pharmacovigilance processes and related training.
- Answer and followup of enquiries from regulatory authorities and other bodies (e.g., Ethics Committees) regarding safetyrelated aspects.
- Implement of the 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 followup of safety data exchange agreements for products assigned.
_ Why you?_:
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Medical Doctor with preferred specialism in Infectious Diseases, Epidemiology or Vaccines
- Minimum 3 years postregistration clinical experience
- 2+ years of 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)
- Very good understanding of GSK Vaccine environment and vaccine development process
- Excellent knowledge of safety regulations and working methods
- Ability to manage crisis, monitor safety issues and work under pressure with a customer and solution oriented approach
- Able to prioritise activities effectively and to meet multiple deadlines successfully with attention to detail, setting high performance standards for quality
- 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
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Demonstrated planning and organizational skills
- Excellent verbal and written communication skills
- Ability to interact with seniorlevel stakeholders across multiple functions
_ Why GSK?_:
Uniting science, technology and talent to get ahead of disease together:
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustai
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