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Senior Pharmacovigilance Specialist for Women's Health
hace 1 mes
We are seeking a highly skilled Senior Pharmacovigilance Specialist to join our team at Organon. As a key member of our safety team, you will be responsible for leading pharmacovigilance activities across various products within Women's Health.
Job DescriptionThe ideal candidate will have 3-5 years of experience in pharmacovigilance and regulatory affairs, with a strong background in international regulations (ICH, GVP/Volume 10, FDA regulations, GCP). You will be responsible for managing adverse event reports, conducting signal detection and risk management planning, and ensuring compliance with global drug safety regulations.
Key Responsibilities:- Lead pharmacovigilance activities for assigned products, including signal detection and risk management planning
- Manage adverse event reports and ensure timely submissions to regulatory authorities
- Develop and implement risk minimization strategies to reduce patient risk
- Collaborate with cross-functional teams to ensure alignment with global risk management strategies
To succeed in this role, you will need:
- Excellent analytical skills to evaluate and interpret safety data
- Strong communication and influencing skills to present complex data to internal and external stakeholders
- Experience with safety databases and IT systems, such as Argus and MS Office
- Fluency in English and proficiency in local language(s) if required
- Postgraduate qualifications in pharmaceutical medicine or a related field, with several years of clinical experience
We offer a competitive annualized salary range of $150,000-$200,000, depending on location and experience. Our benefits package includes comprehensive health insurance, paid time off, and opportunities for professional development.
