Job Description
As a Pharmacovigilance Business Analyst, you will be responsible for ensuring 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 successful candidate will work across teams to gather requirements, implement solutions, and provide support for pharmacovigilance systems such as Argus, ArisG, and Veeva Vault Safety.
* Gather and analyze requirements for pharmacovigilance systems and workflows.
* Work with business users, regulatory teams, and IT to implement or enhance safety systems.
* Document business processes, data flows, and system functionalities related to adverse event reporting.
* Ensure compliance with global regulatory standards.
* 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.
Fundamental qualifications include:
* Bachelor's degree in a relevant field.
* 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.
Preferred skills include:
* Certification in pharmacovigilance.
* Experience with validation and user acceptance testing of PV systems.
Achievable skills include:
* Familiarity with tools and technologies such as pharmacovigilance safety systems.
* Familiarity with adverse event reporting workflows and compliance processes.
* Understanding of global pharmacovigilance regulations.
* Ability to use documentation and reporting tools to support system analysis and validation.
Required Skills and Qualifications
We are seeking an experienced professional who can fulfill the following responsibilities:
1. Possess a Bachelor's degree in a relevant field.
2. Demonstrate in-depth knowledge of pharmacovigilance processes and regulatory requirements.
3. Hold experience working with safety systems such as Argus, ArisG, Veeva Vault Safety.
4. Exhibit strong analytical and problem-solving skills.
5. Show excellent communication and interpersonal abilities.
6. Be able to work collaboratively in cross-functional teams.
Please note that certification in pharmacovigilance and experience with validation and user acceptance testing of PV systems are preferred but not required.
Benefits
This role offers opportunities for personal growth and development in a dynamic and supportive environment.
Others
If you have any questions about this position, please do not hesitate to contact us.