Safety Physician

Basic qualifications:

  • Medical Doctor with preferred expertise in Infectious Diseases, Pediatrics, Epidemiology or Vaccines
  • Ability to apply sound medical judgment in interpretation of safety-related data
  • Able to prioritize 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

Preferred qualifications:

  • Post-residency clinical practice experience
  • 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)

Details:

JOB PURPOSE

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

ACCOUNTABILITY

  • 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

COMPLEXITY

  • 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

Contact information:

You may apply for this position online by selecting the Apply now button.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. 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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

► US - Rockville Video - Rip


Meet Some of GlaxoSmithKline's Employees

Jasdeep

Procurement Associate

Jasdeep finds diverse suppliers to build GSK’s pipeline. He organizes joint ventures with companies and negotiates pricing rates and payments to build a seamless supply system for GSK’s materials and products.

Andrea

HR Associate, Future Leaders Program

Now in her second rotation of GSK’s Human Resources Future Leaders Programme, Andrea is shaping the future of talent management within Research and Development, from workforce assessments to strategy and operations.


Back to top