Local PV Officer - JOB DESCRIPTION

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.

Job Title: Local PV Officer

Location: Argentina

Function: Drug Safety

DESCRIPTION:
Local PV Officer works collaboratively with Integral PV staff, and cross-functional colleagues/teams for pharmacovigilance activities and ensuring regulatory compliance according to the applicable regional and national laws for all medicinal product(s) and territory(ies) for Sitero is responsible. The primary function is to perform translations of the incoming information (safety / non-safety),



managing and supporting pharmacovigilance activities such as conducting non-English follow ups for gathering safety information, local case report distributions & NCA submissions.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Perform translations and/or quality review of the translations (manual / automated) of the incoming information (safety / non-safety).
- Perform accurate, complete, and timely translation of safety-relevant information
- Ensure compliance with international and local guidelines (like GDPR & and applicable data protection laws) into account.
- Should have access to the reports of suspected adverse reactions and assist in monitoring the regulatory submissions.
- Support in preparation of submission packages (local forms in local languages) for local Health Authority case submissions.
- Keep abreast of national pharmacovigilance and regulatory affairs regulations.
- Receive and handle medical information

📌 Local Pharmacovigilance Officer (Buenos Aires)
🏢 Sitero
📍 Buenos Aires