SERM Associate Medical Director / VCSP

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Site Name: Warsaw Cirrus, Belgium-Wavre, Bengaluru Luxor North Tower

Posted Date: Oct 13 2023

SERM Associate Director / for VCSP

Safety Evaluation and Risk Management Associate Director for VCSP (Vaccine Clinical Safety and Pharmacovigilance)

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.

In this role you will …

be involved working in partnership with the VCSP Safety Scientist to deliver the following:

• independent clinical assessments and decisions, based on professional and scientific responsibilities to patients, prescribers, regulators, and providers
• reliable evaluations and recommendations from safety data from large and multinational study environment (200,000 subjects for the ongoing studies)
• scientifically based safety assessments within complex public environment
• cross-functional interactions within GSK Vaccines, such as clinical, regulatory affairs, biostatistics, data management, manufacturing and legal
• external reference for any safety-related request from local authorities and participate in external meetings with regulatory agencies or present.
• 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 project
  
  

Why you?

• Medical Doctor with preferred specialism 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)
• excellent knowledge of safety regulations and working methods
• excellent mastery of English, written and spoken with strong communication and influencing skills
• computer literate, familiar with using scientific and clinical databases
• good administrative skills, analytical mind
• strong leadership and collaborative working skills
  
  

Why GSK?

Our values and expectations are 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.
  
  

Why Us?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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