Pharmacovigilance Expert
il y a 4 semaines
Parexel is seeking a highly skilled Pharmacovigilance Expert to join our team as a Local Qualified Person for Pharmacovigilance (QPPV) in select EMEA locations and Australia.
Key Responsibilities- Manage and implement pharmacovigilance systems, ensuring compliance with local PV legislation and global regulations.
- Provide expert knowledge and guidance on pharmacovigilance risk management, including clinical trials, post-market pharmacovigilance, and safety case processing.
- Develop and maintain pharmacovigilance systems, ensuring quality assurance and adherence to GVP and GCP guidelines.
- Collaborate with cross-functional teams to ensure seamless pharmacovigilance operations.
- Stay up-to-date with evolving pharmacovigilance regulations and guidelines, providing recommendations for process improvements.
- Minimum 7 years' experience in pharmacovigilance, with a strong background in quality assurance and regulatory affairs.
- Extensive knowledge of global pharmacovigilance regulations, including GVP and GCP guidelines.
- Proven track record of managing pharmacovigilance systems and ensuring compliance with regulatory requirements.
- Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams.
- Strong analytical and problem-solving skills, with the ability to interpret complex data and make informed decisions.
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il y a 4 semaines
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il y a 4 semaines
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il y a 4 semaines
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il y a 4 semaines
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il y a 1 jour
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Senior Manager for Pharmacovigilance Operations
il y a 4 semaines
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il y a 4 semaines
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