Pharmacovigilance Business Analyst
Há 6 dias
Title: Pharmacovigilance Business Analyst
Location: Remote
The Pharmacovigilance Business Analyst (PharmaCov BA) will serve as a key liaison between business users, regulatory teams, and IT, ensuring that pharmacovigilance systems and workflows support accurate and compliant adverse event reporting. This role is critical in maintaining patient safety, regulatory compliance, and efficient safety operations. The Business Analyst will work across teams to gather requirements, implement solutions, and provide support for pharmacovigilance systems such as Argus, ArisG, and Veeva Vault Safety.
Roles and Responsibilities:
- Gather and analyze requirements for pharmacovigilance systems and workflows.
- Work with business users, regulatory teams, and IT to implement or enhance safety systems (e.g., Argus, ArisG, Veeva Vault Safety).
- Document business processes, data flows, and system functionalities related to adverse event reporting.
- Ensure compliance with global regulatory standards (e.g., FDA, EMA, MHRA).
- Support validation and user acceptance testing of PV systems.
- Provide support and training to end-users on safety systems and processes.
- Collaborate with cross-functional teams including regulatory affairs, clinical operations, and IT.
Qualifications:
- Bachelor's degree in a relevant field (e.g., Life Sciences, Pharmacy, IT).
- In-depth knowledge of pharmacovigilance processes and regulatory requirements.
- Experience working with safety systems such as Argus, ArisG, Veeva Vault Safety.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal abilities.
- Ability to work collaboratively in cross-functional teams.
Desirable Skills:
- Certification in pharmacovigilance.
- Experience with validation and user acceptance testing of PV systems.
Tools and Technologies:
- Hands-on experience with pharmacovigilance safety systems such as Argus, ArisG, and Veeva Vault Safety.
- Familiarity with adverse event reporting workflows and compliance processes.
- Understanding of global pharmacovigilance regulations (e.g., FDA, EMA, MHRA).
- Ability to use documentation and reporting tools to support system analysis and validation.
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