Senior Pharmacovigilance Expert
1 week ago
About the Job
">This role will be responsible for serving as a scientific expert and pharmacovigilance resource to external and internal partners within the region. The ideal candidate will assess current processes to ensure adherence to local/regional safety regulatory requirements, enhance and/or develop new processes while assuring consistency with global standards.
">Key Responsibilities
">- ">
- Act as point of contact for pharmacovigilance in the assigned countries/region">
- Establish and maintain the applicable pharmacovigilance system specific to the countries/region">
- Promote increased awareness of and ensure compliance with pharmacovigilance obligations for the countries/region">
- Provide support to responses to local pharmacovigilance related regulatory requests">
- Communicate global procedures and practices and monitor implementation">
- Lead the preparation of Pharmacovigilance Agreements (PVA) in collaboration with other departments">
- Engage in due diligence activities as needed in the region when potential business partnerships or collaborations may take place">
- Increase the visibility of the GPS team/function throughout argenx with focus on region">
- Participate in health authority interactions throughout the product life cycle as needed">
- Closely collaborate with other functions including regulatory, medical, communications, quality, legal, as well as other teams as needed">
- Progress understanding and education of safety requirements for pharmacovigilance and other relevant regulations cross-functionally to ensure patient safety and compliance with local and global requirements">
- Maintain an in-depth knowledge of local regulations, expectations and regulatory authority contacts and perform activities related to the interpretation and review of existing and evolving safety requirements">
- Lead and actively participate in GPS audit and inspection readiness, support, and management together with the GPS Quality Management team and the global Quality team">
- Contribute to GPS issue management, recommend and implement action plans for mitigation">
- Identify opportunities to align PV standards globally">
- Maintain knowledge of the Company product portfolio and disease areas for marketed drugs and drugs in development">
- Contribute to the development and evaluation of Key Performance Indicators as related to pharmacovigilance in the region">
- Transparently communicate and/or escalate issues to GPS leadership as appropriate">
- Drive Continuous Improvement initiatives as needed">
- May perform other tasks as appropriate">
About You
">We are seeking a highly skilled Senior Pharmacovigilance Expert with at least 5-8 years of experience in the pharmaceutical/biotech industry, preferably with 3 years in pharmacovigilance/drug safety. You should have a Master's degree in pharmacy, nursing, healthcare, or other life-science or technical field. The ideal candidate should have excellent communication and problem-solving skills, ability to motivate and collaborate with multidisciplinary teams, and fluency in written and spoken English.
">Salary Range:$120,000 - $150,000 per year, depending on experience
">About Lifelancer
">Lifelancer is a talent-hiring platform that connects professionals with opportunities in life sciences, pharma, and IT domains. We strive to inspire and grow our company, partnerships, science, and people to deliver more for patients.
">How to Apply
">Please visit our website at https://lifelancer.com/jobs/view/ccf25d89be388dd2a883277e3efde40a to apply and view similar roles.
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