Job Title:
Pharmacovigilance Business Analyst
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Description
This role requires a unique blend of business acumen, analytical skills, and pharmacovigilance expertise. As a Pharmacovigilance Business Analyst, you will play a crucial part in ensuring that our pharmacovigilance systems support accurate and compliant adverse event reporting.
You will be responsible for liaising between business users, regulatory teams, and IT to guarantee the seamless integration of pharmacovigilance processes and systems. This includes gathering and analyzing requirements for pharmacovigilance systems and workflows, implementing or enhancing safety systems, documenting business processes, data flows, and system functionalities related to adverse event reporting, ensuring compliance with global regulatory standards, supporting validation and user acceptance testing of PV systems, providing support and training to end-users on safety systems and processes, and collaborating with cross-functional teams including regulatory affairs, clinical operations, and IT.
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Required Skills and Qualifications
To succeed in this role, you will need a strong foundation in pharmacovigilance processes and regulatory requirements. You should have a Bachelor's degree in a relevant field such as Life Sciences, Pharmacy, or IT, along with in-depth knowledge of pharmacovigilance processes and regulatory requirements. Additionally, you should have hands-on experience working with safety systems such as Argus, ArisG, and Veeva Vault Safety, strong analytical and problem-solving skills, excellent communication and interpersonal abilities, and the ability to work collaboratively in cross-functional teams.
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Benefits
We offer a range of benefits to our employees, including opportunities for professional growth and development, a dynamic and supportive work environment, and a competitive salary package.
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Others
This is an exciting opportunity to join our team and contribute to the success of our organization. If you are a motivated and talented individual with a passion for pharmacovigilance, we encourage you to apply for this role.