Job Title: Pharmacovigilance Business Analyst
Location: Remote
Job Description:
The key objective of the Pharmacovigilance Business Analyst is to serve as a liaison between business users, regulatory teams, and IT. This role is pivotal in maintaining patient safety, regulatory compliance, and efficient safety operations.
Key responsibilities include gathering and analyzing requirements for pharmacovigilance systems and workflows. Additionally, the Business Analyst will work with stakeholders to implement or enhance safety systems such as Argus, ArisG, and Veeva Vault Safety.
Documentation of business processes, data flows, and system functionalities related to adverse event reporting is also a critical aspect of this role. Compliance with global regulatory standards is essential, and the Analyst must ensure that all relevant guidelines are adhered to.
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.
Benefits:
As a Pharmacovigilance Business Analyst, you will have the opportunity to work collaboratively with cross-functional teams. You will be responsible for providing support and training to end-users on safety systems and processes.
Tools and Technologies:
Proficiency in pharmacovigilance safety systems such as Argus, ArisG, and Veeva Vault Safety is essential. Familiarity with adverse event reporting workflows and compliance processes is also necessary.
Responsibilities:
1. Implement or enhance safety systems.
2. Document business processes.
3. Ensure compliance with regulatory standards.
4. Support validation and user acceptance testing.
5. Provide training to end-users.