Job Title: Pharmacovigilance Business Analyst
The role involves serving as a key liaison between business users, regulatory teams, and IT to ensure that pharmacovigilance systems and workflows support accurate and compliant adverse event reporting.
1. Key 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.
2. Required Skills and 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.
3. Desirable Skills:
* Certification in pharmacovigilance.
* Experience with validation and user acceptance testing of PV systems.
4. 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.
Why This Role Matters: Maintaining patient safety, regulatory compliance, and efficient safety operations is critical in this role.
About the Job: We are looking for a skilled Pharmacovigilance Business Analyst to join our team.