Pharmacovigilance Aggregate Reporting Lead

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Pharmacovigilance Aggregate Reporting Lead 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 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 agevolazioni-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:
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 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. Disclaimer By
attaching your Curriculum Vitae (CV), resume, and/or completing an
online application, you are consenting to the collection,
processing, use, transfer (including but not limited to other
countries/jurisdictions), storage, and disclosure of your personal
data as described in the Med Communications, Inc. Privacy Policy .
Please read this policy carefully for more information on your
rights regarding personal data protection. We are an equal
opportunity employer and all qualified applicants will receive
consideration for employment without regard to race, color,
religion, sex, national origin, age, disability, genetic
information, or veteran status. Recruitment Agency Notice: Thank
you for your interest in working with Med Communications. We kindly
ask that recruitment agencies avoid sending unsolicited CVs, as our
in-house team manages all hiring processes. Please be aware that
any unsolicited CVs or candidate profiles received without prior
engagement or agreement with our recruitment team will be
considered free and carry no obligation on the part of Med
Communications. We thank you for your compliance with our policy.
Should collaboration opportunities arise, we will reach out to
preferred partners proactively. Your understanding and cooperation
are appreciated.

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7a066f