Pharmacovigilance Aggregate Reporting Lead

Position Summary

Essential Functions
- Lead and supervise the planning, writing, compilation, quality review and submission of PSURs/PBRERs, DSURs, PADERs, ADCOs, Line Listings for assigned client products.
- Develop and maintain aggregate reporting timelines and submission schedules, ensuring alignment with IBDs, data lock points and regulatory submission deadlines.
- Coordinate data collection from all relevant teams to ensure report completeness and accuracy.
- Integrate signal evaluation outcomes and benefit-risk assessments into periodic safety reports in collaboration with the Signal Management Lead and medical reviewers.
- Review and quality-check safety database outputs (line listings, summary tabulations, etc) for inclusion in aggregate reports.
- Author or oversee authoring of case narratives, cumulative analyses, and benefit-risk evaluation sections.
- Manage the review and approval workflow for aggregate reports, coordinating input from medical reviewers, the QPPV and client stakeholders, as appropriate.




- Contribute to Risk Management Plans (RMPs) and REMS safety sections as required.
- Lead, supervise and mentor PV Specialists and Sr. PV Specialists assigned to perform aggregate reporting support activities.
- Develop and review SOPs, Work Instructions and report templates related to aggregate reporting in collaboration with the PV Quality Manager.
- Maintain up-to-date knowledge of integral aggregate reporting requirements and proactively communicate regulatory changes to the PV team and clients.
- Ensure inspection and audit readiness and actively support QA activities including CAPA follow-up.
- Comply with all applicable guidelines, policies, legal, regulatory, and compliance requirements.

Education:
Advanced degree in life sciences - pharmacy (PharmD), or Medicine(MD) preferred.
A postgraduate qualification in regulatory affairs, Pharmacoepidemiology, or drug safety is an advantage.

Experience: Minimum

📌 Pharmacovigilance Aggregate Reporting Lead (Buenos Aires)
🏢 Med Communications International
📍 Buenos Aires