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Outsourcing and Consulting Services
for Life Sciences
BROCHURE
Steering through Stringent
Pharmacovigilance Requirements
CHALLENGE
In 2012, the European Medicines Agency (EMA) made a significant change in the
regulation of human medicines by enacting new pharmacovigilance (PV)
legislation. The purpose of the legislation was to reduce the number of adverse
drug reactions and events by way of the collection of better data on medicines,
rapid and robust assessment and correction of safety issues, effective regulatory
action for the delivery of safe and effective use of medicines, patient
empowerment through reporting and participation, better transparency, and
extensive communication.
To enhance PV activities, the EMA introduced a set of
good-pharmacovigilance-practice (GVP) measures. The GVP guideline includes
a series of modules that cover major PV processes, including pharmacovigilance
system master files (PSMFs), inspections, audits, risk management systems,
management and reporting of adverse reactions to medicinal products, and
periodic safety update reports/periodic benefit-risk evaluation reports
(PSURs/PBRERs).
Pharmaceutical companies have had to make adjustments to meet the new
requirements, and they continue to face challenges in meeting their GVP
commitments. For example, not only does the PSMF have to be written, but
also—because it is a live document—it must be continually updated and
maintained. As a result, many companies struggle with the level of detail
they must produce in the creation and maintenance of the PSMF.
Many other PV requirements, too, generate huge additional workloads for already
stretched internal PV teams, making it difficult for companies to meet all of the
stipulated GVP guideline requirements. And those challenges will only intensify
with the release—later in 2015—of several other major GVP modules, including
public participation in PV, safety-related action on authorised medicinal products,
and international cooperation.
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www.productlifegroup.com
Outsourcing and Consulting Services
for Life Sciences
Audits/authority inspec ons
EudraCT, EudraVigilance
registra on & provision
responsible person
Phase I
Phase II
Phase III
PV-System Master File (PSMF) crea on and maintenance
RMP
Phase IV
PostmarkeƟng
DSUR
PSUR (PBRER/PA(D)ER)
Local Qualified Person or Local PV Contacts
Authorised product informa on
ICSR handling (AE/ADR-repor ng)
Product launch
QPPV
Proposed
AE-/SUSAR-repor ng
Marke ng
authorisa on
applica on
Marke ng authorisa on with/without obliga on
Renewal
Varia on
Addi onal monitoring
Proof of safety & eﬃcacy
Signal management
EVMPD repor ng
Regulatory eﬀort/administra on: Also increasing in life cycle
PRAC/CMDh:
Art. 31/Art. 107 i
Art.31/Art.20
Referrals
PASS/PAES
PSUR (PBRER) assessments
Var.: Prod. Type II Varia on/PSMF
USR/DDL
Safety Signals
EURD lists
OFFERINGS
ProductLife Group (PLG) offers PV services across the product life cycle, from clinical
trials to postmarketing. We can provide clients with either every service needed during
every phase or only those services clients cannot support. PLG’s expertise at the
clinical-trial level covers the entire clinical safety process, including EudraVigilance
registration, provision of responsible person, preparation of safety management plan,
serious-adverse-event reporting, suspected-unexpected-serious-adverse-reaction
reporting (SUSARs) (globally), and Development Safety Update Report (DSUR)
preparation.
PLG’s expertise in postmarketing pharmacovigilance also covers the entire suite of
services that may be needed, including provision of European Union qualified person
for pharmacovigilance (QPPV), local qualified person for pharmacovigilance (LQPPV),
and local contact person for pharmacovigilance (LCPPV); literature searching at a
global and/or national level, preparation and maintenance of PSMFs, PSURs/PBRERs,
and risk management plans (RMPs); processing of Individual Case Safety Reports
(ICSRs); signal detection and management; EudraVigilance Medicinal Product
Dictionary updates; support of client audits; and interactions with the
Pharmacovigilance Risk Assessment Committee (PRAC).
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BROCHURE
ProductLife Group’s expert clinical safety and pharmacovigilance team comprises the following members.
PV Associate (PVA) and PVAs
Ensure accuracy of data entered into the safety database (DB)
Ensure QC, ICSR validation & submission
Responsible for the appropriate routine & ad hoc
literature search into Global (e.g., Embase,
Pubmed) and in local DB (e.g. Pascal)
Performs the review of the narratives
as part of the QC process
PV Officer (PVO) & Senior PVOs
Ensure accuracy of data entered
into the safety DB
Ensure QC, ICSR validation & submission
Ensure any operation PV activities
related to DSUR/PSUR-PBRER/
DRMP-RMP & CTD processing
Provided by senior PVOs
Medical writing / aggregate
report writing
RMP preparation etc.
Performs the review of the narratives as
part of the QC process
PV Compliance Manager
Ensure PSMF management
Ensure CAPA management
Ensure SOP writing review
Ensure KPI management
Ensure PV training
Regulatory Intelligence Officer
Ensure routine and ad hoc regulatory
intelligence in PV (e.g. PRAC
recommendations)
Maintain expedited reporting
requirements
Safety Physician (Medical Advisor)
Medical review of literature and safety
report of cases
Responsible for medical assessment of
ICSR DSUR / PSUR-PBRER, DRMP-RMP
and any safety document (e.g. CTD)
Ensure signal assessment & continuous
B/R evaluation
Review/sign-off post-auth. Study
protocols/IB
PHARMACOVIGILANCE
Data Entry Associate
Enter the data received
in the safety DB (initial
and follow-up reports)
Ensure MedDRA precoding
Database Experts
Responsible for the safety DB
validation and maintenance
Ensure any routine and ad hoc
enquiries in the safety database
XEVMPD registration / update
Local QPPV / Local Contact
Provides local PV services according
to local regulations, that cannot be
provided by client HQ, can include (ICSR,
PSUR, RMP…) , local literature search
Key contact person for local authorities
Should report to the EEA QPPV
EEA QPPV and Deputy EEA QPPV
Responsible for establishment and maintenance of the
MAH’s PV system according to the applicable regulation
Shall have authority to influence the performance of
the quality system and the PV activities
Is the key contact for authorities (e.g. inspection)
Reviews all PV deliverables
PV Operations Manager
Management of PV teams including workload management
and resource allocation
Continuous improvement of operational processes of PV department
Ensure processes meet global safety reporting requirements and
processes for compliance fully assess the accuracy, quality and
regulatory compliance of PV department’s outputs
In addition, all roles are supported by the Head of Quality to ensure:
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Maintenance and ongoing improvement of PLG quality system
Implementation of PLG annual audit programme, including PV system and vendor audits
Support for regulatory authority inspections of MAH PV system
Hosting client audits of quality and PV systems and project delivery
ProductLife Group Head Office
40 Boulevard Henri Sellier, 92150 Suresnes, France
Tel. +33 1 41 44 22 11 • info@productlife-group.com
BELGIUM • FRANCE • GERMANY • ITALY • SWITZERLAND
• UNITED KINGDOM
ProductLife Group is a trusted partner that helps clients stay ahead of the changing R&D landscape. We provide support across
all stages of the product life cycle and have experience in working with companies in all segments of the life sciences industry.
With an established presence in five European countries, extensive capabilities in key markets, and more than two decades of
serving the industry, ProductLife Group has a solid platform from which to provide clients a range of services, consulting, and
outsourcing solutions. We empower clients to focus on innovation and business growth strategies and to make strong, informed
decisions every step of the way. What’s more, we wrap it all up with partnership flexibility, for a truly custom experience that
helps clients scale the initiatives cost-effectively.
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By leveraging the power of deep domain expertise, relationships, collaboration, and a flexible delivery framework, ProductLife
Group delivers exceptional service to clients. Our goal is to develop long-term relationships by being responsive and relevant
and by consistently delivering value. We cultivate a trusting, consultative environment and are positioned to operate as an
extension of clients’ businesses, with a shared interest in their long-term success.
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