Senior Pharmaceutical Risk Manager
Há 2 dias
Job Title: Pharmacovigilance Business Analyst
The Pharmacovigilance Business Analyst plays a vital role in ensuring accurate and compliant adverse event reporting. This position requires collaboration with business users, regulatory teams, and IT to maintain patient safety and efficient safety operations.
Key Responsibilities:
- Gather and analyze requirements for pharmacovigilance systems and workflows.
- Implement or enhance safety systems such as Argus, ArisG, and 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.
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.
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 (e.g., FDA, EMA, MHRA).
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