Job Summary
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* The Pharmacovigilance Business Analyst serves as a vital liaison between business stakeholders, regulatory teams, and IT to ensure accurate and compliant adverse event reporting.
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Main Responsibilities:
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* Gather and analyze requirements for pharmacovigilance systems and workflows, ensuring seamless integration with existing infrastructure.
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* Implement or enhance safety systems such as Argus, ArisG, and Veeva Vault Safety, leveraging technical expertise to drive process improvements.
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* Document business processes, data flows, and system functionalities related to adverse event reporting, providing actionable insights for key stakeholders.
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* Maintain compliance with global regulatory standards like FDA, EMA, MHRA, through meticulous adherence to regulations and guidelines.
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* Support validation and user acceptance testing of PV systems, guaranteeing high-quality deliverables that meet business needs.
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* Deliver training to end-users on safety systems and processes, fostering knowledge sharing and collaboration across the organization.
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* Collaborate with cross-functional teams including regulatory affairs, clinical operations, and IT, promoting a culture of transparency and open communication.
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Requirements:
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* Bachelor's degree in Life Sciences, Pharmacy, or IT, demonstrating academic achievement and foundation in relevant field.
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* In-depth knowledge of pharmacovigilance processes and regulatory requirements, staying up-to-date with industry developments and trends.
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* Experience working with safety systems such as Argus, ArisG, Veeva Vault Safety, showcasing technical expertise and adaptability in fast-paced environment.
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* Strong analytical and problem-solving skills, applying logical reasoning and creativity to resolve complex challenges.
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* Excellent communication and interpersonal abilities, building strong relationships with stakeholders and driving collaborative outcomes.
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* Ability to work collaboratively in cross-functional teams, embracing diverse perspectives and driving collective success.
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