Pharmacovigilance Business Analyst

3 semanas atrás

Porto Alegre, Rio Grande do Sul, Brasil Hyqoo Tempo inteiro

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).

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