Pharmacovigilance Expert
4 weeks ago
We are seeking a highly skilled Pharmacovigilance Expert to join our team at 1925 GlaxoSmithKline LLC. As a key member of our Safety Evaluation and Risk Management (SERM) group, you will be responsible for ensuring the safe and effective use of our pharmaceutical products.
Key Responsibilities- Lead pharmacovigilance and risk management planning, developing strategies for the evaluation of safety issues in clinical development and post-marketing settings.
- Develop and implement safety strategies for global regulatory submissions, ensuring compliance with international pharmacovigilance requirements.
- Provide expert evaluation and analytical skills for literature review, clinical data synthesis, analysis, and interpretation.
- Make quality decisions and resolve complex problems, considering all relevant information and factors.
- Develop and maintain strong working relationships with cross-functional teams, including regulatory authorities, licensing partners, and other stakeholders.
- Advanced degree in a life science discipline or relevant experience.
- Significant experience in pharmacovigilance, safety evaluation, and risk management, with a focus on clinical development and post-marketing activities.
- Knowledge of international pharmacovigilance requirements, including ICH, GVP modules, and CIOMS initiatives.
- Strong leadership and communication skills, with the ability to work effectively in a matrix team environment.
- Ability to work across global sites and adapt to changing priorities and deadlines.
At 1925 GlaxoSmithKline LLC, we are committed to uniting science, technology, and talent to get ahead of disease together. We are a global biopharma company with a special purpose – to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns. We prevent and treat disease with vaccines, specialty, and general medicines, focusing on the science of the immune system and the use of new platform and data technologies.
We are an equal opportunity employer, committed to diversity and inclusion. We believe in an agile working culture for all our roles, and we encourage you to explore with our hiring team what the opportunities are.
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