[Hiring] Pharmacovigilance Lead Aggregate Reporting @Med Communications International

Role Description

The PV Aggregate Reporting Lead is a senior expert responsible for leading, coordinating, and overseeing the preparation and submission of aggregate safety reports across assigned client portfolios. The role encompasses the full lifecycle of periodic and aggregate reporting — including PSURs/PBRERs, DSURs, PADERs, ADCOs, and Line Listings, in compliance with EMA GVP Module VII, ICH E2C(R2), ICH E2F, and FDA requirements.

The role acts as the subject matter expert for aggregate reporting and collaborates with signal management, case processing, medical review, and client teams to deliver submission-ready documents within regulatory deadlines.

• 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 global 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.

Qualifications

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

Requirements

• Minimum 4 years of PV experience, with at least 2 years focused on aggregate/periodic safety report writing at a PV vendor, CRO, or pharmaceutical company.
• End-to-end PSUR/PBRER experience required; DSURs, PADERs, and RMPs strongly preferred.
• Safety databases (like Oracle Argus Safety, ArisG LifeSphere, Veeva Safety, AB Cube Safety), document management systems, Microsoft Office Suite (Word, Excel, Outlook, PowerPoint), literature databases (Embase, PubMed).
• Familiarity with electronic submission tools and aggregate reporting softwares is an advantage.

Company Description