Safety Physician SERM (Safety Evaluation and Risk Management)

Job description

Details:
Be part of a new team for an exciting and growing business and world's leading vaccine organization in our new R&D Center in Rockville, Md.

We are seeking Safety Physicians to support two divisions within the GSK Rockville Vaccines group. You will have the opportunity to be on the ground floor of a new organization and site, and you will be part of a new culture of some of the best scientific minds in vaccine research. Come deliver the GSK Vaccines strategy by driving vaccine R&D projects through innovation, collaboration, cutting edge science, exceptional people, and end-to-end quality performance.

You will 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:

You will 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

You will perform medical review and provide medical advice on safety-related 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
Development and revision of assigned central pharmacovigilance processes and related training.
Answering and follow-up of enquiries from regulatory authorities and other bodies (e.g., Ethics Committees) regarding safety-related aspects.
Implementation 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.
Implementation and follow-up of safety data exchange agreements for products assigned.

Provide 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.

Location: Rockville, Maryland

*LI-GSK

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 (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.

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Desired profile

Basic qualifications:
Medical Doctor with preferred specialization in Infectious Diseases, Epidemiology or Vaccines
Minimum 3 years post-registration 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).
Knowledge of the Vaccines environment and vaccine development process

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Preferred qualifications:
Ability to manage crisis, monitor safety issues and work under pressure with a customer and solution oriented approach.
Able to prioritize 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