Job Title:
Pharmacovigilance Business Analyst
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Description of Job Responsibilities:
The role of a Pharmacovigilance Business Analyst involves acting as a liaison between business users, regulatory teams and IT departments. This includes gathering and analyzing requirements for pharmacovigilance systems and workflows, working with various stakeholders to implement or enhance safety systems such as Argus, ArisG and Veeva Vault Safety, documenting business processes data flows and system functionalities related to adverse event reporting, ensuring compliance with global regulatory standards like FDA, EMA and MHRA, 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.
Required Skills and Qualifications:
* A Bachelor's degree in a relevant field such as Life Sciences, Pharmacy or IT.
* In-depth knowledge of pharmacovigilance processes and regulatory requirements.
* Experience working with safety systems such as Argus, ArisG and 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 such as FDA, EMA and MHRA.
* Ability to use documentation and reporting tools to support system analysis and validation.
Key Responsibilities:
1. Gather and analyze requirements for pharmacovigilance systems and workflows.
2. Work with business users, regulatory teams and IT to implement or enhance safety systems.
3. Document business processes data flows and system functionalities related to adverse event reporting.
4. Ensure compliance with global regulatory standards.
5. Support validation and user acceptance testing of PV systems.
6. Provide support and training to end-users on safety systems and processes.
7. Collaborate with cross-functional teams.
Professional Requirements:
* Bachelor's degree in a relevant field.
* In-depth knowledge of pharmacovigilance processes and regulatory requirements.
* Experience working with safety systems.
* Strong analytical and problem-solving skills.
* Excellent communication and interpersonal abilities.
* Ability to work collaboratively in cross-functional teams.
Prioritization of Key Functions:
* Maintaining regulatory compliance.
* Ensuring quality and efficiency of pharmacovigilance systems.
* Providing effective communication and collaboration with stakeholders.
* Enhancing organizational capabilities through technology adoption.