About Company
GSK (GlaxoSmithKline) is a global biopharma company with a clear purpose: to unite science, technology, and talent to get ahead of disease together. We are committed to positively impacting the health of 2.5 billion people over the next 10 years by focusing on the science of the immune system, human genetics, and advanced technologies. Our innovative pipeline is driven by a mission to deliver vaccines and specialty medicines that improve and save lives worldwide. At GSK, you’ll be part of a diverse and inclusive team that values collaboration, scientific rigor, and a deep commitment to patient safety. Join us in making a tangible difference in global health and contributing to a healthier future for all.
Job Description
As a Pharmacovigilance Associate at GSK, based in our Bermuda Springs, Margate office, you will be at the forefront of ensuring the safety of our medicines and vaccines. This pivotal role involves the meticulous collection, processing, and reporting of adverse event (AE) information from various sources. Your work will directly support our adherence to stringent global regulatory requirements and internal standard operating procedures, ensuring the highest standards of data quality and integrity. This position offers a stimulating opportunity to contribute significantly to patient safety within a dynamic, fast-paced environment. You will collaborate closely with cross-functional teams including clinical development, regulatory affairs, and medical affairs, leveraging your exceptional attention to detail and analytical skills to ensure timely and accurate pharmacovigilance activities. Your dedication to scientific rigor and ethical practice will be critical in maintaining public trust and supporting healthcare professionals and patients. This role is ideal for a proactive and detail-oriented individual eager to embark on or advance their career in the pharmaceutical industry, making a meaningful impact within a leading global biopharma company dedicated to improving health worldwide. We are seeking someone who is adaptable, keen to learn, and passionate about contributing to a healthier future.
Key Responsibilities
- Receive, triage, and process adverse event reports from various sources, ensuring data accuracy and completeness.
- Perform medical coding of adverse events and drug terms using MedDRA and WHO-DD terminologies.
- Conduct initial case assessment and write comprehensive narratives for individual case safety reports (ICSRs).
- Assist in the preparation, review, and submission of expedited and aggregate safety reports to regulatory authorities globally.
- Maintain up-to-date knowledge of global pharmacovigilance regulations, guidelines (e.g., ICH, FDA, EMA), and internal standard operating procedures.
- Collaborate effectively with internal departments, including Clinical Operations, Regulatory Affairs, and Medical Affairs, to facilitate seamless data exchange and safety communication.
- Participate in quality control activities to ensure compliance with pharmacovigilance requirements and internal quality standards.
- Support departmental training initiatives and contribute to process improvement projects to enhance efficiency and effectiveness.
- Respond to safety-related inquiries from internal and external stakeholders in a timely and professional manner.
Required Skills
- Bachelor's degree in a life science, pharmacy, nursing, or a related healthcare field.
- Minimum of 2 years of experience in pharmacovigilance, drug safety, or a related pharmaceutical safety role.
- Solid understanding of global pharmacovigilance regulations and guidelines (e.g., ICH, FDA, EMA).
- Proficiency in medical terminology and adverse event coding systems (e.g., MedDRA, WHO-DD).
- Exceptional attention to detail and strong organizational and time management skills.
- Excellent written and verbal communication skills in English, with the ability to articulate complex information clearly.
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
Preferred Qualifications
- Master's degree or PharmD.
- Prior experience with safety databases such as Argus or ArisG.
- Familiarity with clinical trial processes and the drug development lifecycle.
- Demonstrated ability to work independently and collaboratively in a fast-paced, matrixed environment.
- Previous experience working within a global pharmaceutical company.
Perks & Benefits
- Competitive base salary and annual performance-based bonuses.
- Comprehensive health, dental, and vision insurance plans for employees and their families.
- 401(k) retirement plan with attractive company matching contributions.
- Generous paid time off policy, including vacation, holidays, and sick leave.
- Extensive opportunities for professional development, training, and career advancement within a global organization.
- Employee assistance program and robust wellness initiatives to support work-life balance.
- Tuition reimbursement program for continuous learning and skill enhancement.
- Access to on-site fitness centers (where applicable) or subsidized wellness programs.
How to Apply
If you are a highly motivated and detail-oriented professional with a passion for patient safety and possess the required qualifications, we encourage you to apply for this exciting opportunity. Please click on the application link below to submit your comprehensive resume and a compelling cover letter directly through our official careers portal. We look forward to reviewing your application and discovering how your expertise can contribute to GSK’s mission of improving global health.