Pharmacovigilance Lead Aggregate Reporting

Pharmacovigilance Lead Aggregate Reporting

Position Summary

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.

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 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.

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 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.

Computer Skills: Safety databases (like Oracle Argus Safety, ArisG LifeSphere, Veeva Safety, AB Cube SafetyEasy), 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.

Competency Statements

• Self-Motivated - Ability to be internally inspired to perform a task to the best of ones ability using his or her own drive or initiative.
• Above average attention to detail, teamwork, and initiative.
• Organized - Possesses the trait of being well organized or following a systematic method of performing a task.
• Accuracy - Ability to perform work accurately and thoroughly.
• Technical Aptitude - Ability to comprehend complex technical topics and specialized information.
• Tactful - Ability to show consideration for and maintain good relations with others.
• Responsible - Ability to be held accountable or answerable for ones conduct.
• Problem Solving - Ability to find a solution for or to deal proactively with work-related problems.
• Active Listening - Ability to actively attend to, convey, and understand the comments and questions of others.
• Customer Oriented - Ability to take care of the clients needs while following company procedures.
• Communication, Written - Ability to communicate in writing clearly and concisely.
• Communication, Oral - Ability to communicate effectively with others using the spoken word.
• Applied Learning - Ability to participate in needed learning activities in a way that makes the most of the learning experience.

Work Environment

Remote: Romania / Poland or Portugal

The company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills, and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the company reserves the right to change this job description and/or assign tasks for the employee to perform, as the company may deem appropriate.

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