Pharmacovigilance Aggregate Reporting Lead

remote zest jobs; India; On-site; INR 2,400,000 - 3,600,000; Full time

Job summary

N/A is seeking a senior PV Aggregate Reporting Lead to oversee the preparation and submission of aggregate safety reports across assigned portfolios, ensuring compliance with EMA, ICH and FDA requirements. The role requires coordination with signal management, medical review and regulatory teams to meet deadlines.

Responsibilities include leading PSURs/PBRERs, DSURs, PADERs, and line listings, maintaining submission timelines, and ensuring data quality for regulatory submissions.

Qualifications

• Minimum 4 years of PV experience with at least 2 years in aggregate/periodic safety report writing. End-to-end PSUR/PBRER experience required; DSURs, PADERs, and RMPs preferred.
• Strong data collection, review and quality control for safety reports and line listings.

Responsibilities

• Lead planning, writing, compilation, quality review and submission of PSURs/PBRERs, DSURs, PADERs, ADCOs and line listings.
• Maintain reporting timelines and submission schedules aligned with regulatory deadlines.
• Coordinate data collection from relevant teams to ensure completeness and accuracy.
• Author case narratives, cumulative analyses and benefit-risk sections.
• Manage review workflow with medical reviewers, QPPV and stakeholders.
• Contribute to RMPs and REMS safety sections as required.
• Mentor PV Specialists and ensure SOP compliance.

Skills

PV experience

Aggregate reporting

PSURs/PBRERs

DSURs/PADERs/RMPs

Regulatory compliance

Education

Advanced degree in life sciences - PharmD/MD

Postgraduate regulatory qualification

Tools

Argus Safety

ArisG LifeSphere

SafetyEasy

Office Suite (Word, PowerPoint, Outlook)

Embase

PubMed

Job description

Position Summary

The Pharmacovigilance Aggregate Reporting Lead is a senior expert responsible for leading, coordinating, and overseeing the preparation and submission of aggregate safety reports across assigned reputed company 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(reputed company), 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 reputed company teams to deliver submission-reputed company documents reputed company 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 reputed company products.
• reputed company and maintain aggregate reporting timelines and submission schedules, ensuring alignment with IBDs, data lock points and regulatory submission deadlines.
• Coordinate data collection from reputed company relevant teams to ensure report completeness and accuracy.
• reputed company signal evaluation reputed company and benefit-risk assessments into periodic safety reports in collaboration with the Signal Management Lead and medical reviewers.
• Review and quality-reputed company safety database outputs (line listings, summary tabulations, etc) for inclusion in aggregate reports.
• Author or reputed company 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 reputed company 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 reputed company aggregate reporting support activities.
• reputed company and review SOPs, Work Instructions and report templates reputed company 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.
• reputed company with reputed company 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 reputed company 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 reputed company Argus Safety, ArisG LifeSphere, reputed company Safety, AB reputed company SafetyEasy), document management systems, reputed company Office Suite (Word, reputed company, 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 reputed company 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 reputed company organized or following a systematic method of performing a task.
• Accuracy - Ability to reputed company work accurately and thoroughly.
• Technical Aptitude - Ability to comprehend reputed company 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 reputed company a solution for or to deal proactively with work-reputed company problems.
• reputed company 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 reputed company 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 reputed company.

Work Environment

Remote: Italy, 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 reputed company guidelines fo