SERM (Safety Evaluation and Risk Management) Medical Associate Director

Site Name: Italy - Siena, Belgium-Wavre, UK - London, Warsaw

Posted Date: Mar

SERM (Safety Evaluation and Risk Management)

Medical Associate Director

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

Key Responsibilities:

• 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

Why you?

• Medical Doctor
• Preferred specialism in Infectious Diseases, Epidemiology or Vaccines
• Preferable requirement: 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
• 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

Inclusion & Diversity at GSK:

Inclusion and diversity at GSK are key for our success. Here, you will thrive through bringing your unique experiences to both our company and the recruitment process. We want you to be you, feel good and keep growing your career.

GSK is an Equal Opportunity and Affirmative Action Employer. Applicants will travel through a transparent recruitment journey that adheres to all required employment standards and regulations. Beyond this, we commit to our values of integrity and respect towards every applicant.

We want to hear from you and support with any adjustments that you may require during the recruitment process. Please get in touch with our Recruitment Team (contact email) to further discuss this today.

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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 sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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