Job Title: Pharmacovigilance Business Analyst (PharmaCov BA)
Duration: 6 to 12 months with possible extension or FTE conversion after 6 months.
Location: Remote (Brazil)
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.
Required Skills:
- 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.
"Education Qualification"
- Bachelor's degree in a relevant field (e.g., Life Sciences, Pharmacy, IT).