SERM Senior Scientist
2 days ago
Position Summary:
Are you passionate about ensuring patient safety and advancing global health? As a Senior Scientist in Safety Evaluation and Risk Management (SERM), you will play a key role in monitoring and evaluating the safety of our products. You will collaborate with cross-functional teams to identify, assess, and manage safety risks, ensuring compliance with global regulatory standards. We value candidates who are detail-oriented, proactive, and committed to making a positive impact on patient lives.
Responsibilities:
Responsible for safety monitoring and evaluation of assigned GSK products.
Conduct safety monitoring and evaluation for assigned products, including signal detection and risk assessment.
Review and analyze individual case safety reports (ICSRs) and literature for safety signals.
Draft and contribute to regulatory documents, including periodic safety reports and risk management plans.
Collaborate with cross-functional teams to address safety-related queries and ensure compliance with regulatory requirements.
Provide input on labeling updates and safety-related documentation.
Mentor junior colleagues and contribute to process improvement initiatives within the safety team.
Basic Qualifications:
Bachelor's degree in Life Sciences, Pharmacy, or a related field. Advanced degree (e.g., Master's, PhD, PharmD) in Life Sciences or a medical field preferred.
Familiarity with safety databases and tools.
Experience in pharmacovigilance, safety surveillance, or drug development.
Knowledge of global regulatory requirements and safety data management.
Strong analytical and communication skills.
Ability to work effectively in a matrix environment.
Experience in drafting aggregate safety documents and risk management plans.
Preferred Qualifications:
Advanced degree (e.g., Master's, PhD, PharmD) in Life Sciences or a medical field.
Previous experience as a healthcare professional (e.g., pharmacist, nurse).
Familiarity with safety databases and tools.
Demonstrated ability to mentor and train team members.
Experience in drafting regulatory documents and risk management plans.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
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