Pharmacovigilance - Project Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/79ynth

Pharmacovigilance Project Manager (Remote) Position
Summary The Pharmacovigilance Project Manager / Project Lead is a
senior client-facing professional responsible for the end-to-end
operational management of one or more assigned pharmacovigilance
client accounts at Med Communications. The role serves as the
primary interface between the client and the MC PV team, ensuring
the timely, high-quality, and fully compliant delivery of all
contracted pharmacovigilance services across case management,
periodic reporting, signal detection, risk management, and related
regulatory activities. Operating at a senior level within the PV
department, the PV Project Manager / Project Lead combines strong
scientific and regulatory knowledge with exceptional project
management, communication, and stakeholder management capabilities.
The role does not carry direct line management responsibility but
exercises functional oversight of PV Specialists and Sr. PV
Specialists assigned to the project, coordinating their workload,
guiding their day-to-day activities, and supporting their
professional development within the context of the client
engagement. The role reports directly to the Global Head of
Pharmacovigilance and Drug Safety. Essential Functions To perform
this job successfully, an individual must be able to perform each
essential duty satisfactorily. Reasonable accommodation may be made
to enable qualified individuals with disabilities to perform the
essential functions. Essential Functions Statement(s): Client and
Account Management: Serve as the primary point of contact for all
communications between the client and the MC PV team, ensuring
professional, accurate, and timely responses to all client
enquiries and requests. Build and maintain a strong, trust-based
relationship with client stakeholders, including the client's
pharmacovigilance, regulatory, medical, and quality teams, as
applicable Coordinate, schedule, and lead regular client meetings,
teleconferences, and governance reviews; prepare agendas, minutes,
and action items and ensure timely follow-up on all open items.
Immediately escalate to the Global Head of PV and PVQM any breach
in normal execution of contracted activities, service-level
deviations, or issues that could impact the client's regulatory
compliance position. Identify opportunities for additional services
or expanded scope within existing client engagements and
communicate these to the Global Head of PV. Coordinate the
onboarding of new clients or new product additions, including the
organisation of training curricula, implementation plans, and
system access for the assigned PV team, in collaboration with the
PVQM. Operational Project Management: Oversee and coordinate the
day-to-day PV activities of the assigned project team — including
case processing, literature review, periodic and aggregate
reporting, signal detection, and risk management — ensuring all
activities are executed in compliance with applicable SOPs,
client-specific procedures, and regulatory requirements (EMA GVP,
ICH, FDA, UK MHRA, and others as applicable). Plan, monitor, and
adjust resource allocation across the assigned project team to
ensure adequate coverage, equitable workload distribution, and
consistent delivery of contracted service levels. Maintain and
regularly update project documentation, tracking tools, and network
files to ensure completeness, accuracy, and accessibility for all
relevant team members. Monitor project-level metrics and Key
Performance Indicators (KPIs), identify trends or risks, and
proactively implement corrective measures in collaboration with the
Global Head of PV. Coordinate directly with the PVQM and relevant
internal stakeholders regarding any updated client operational
procedures, regulatory changes, or system modifications requiring
team training or process updates. Communicate and ensure
integration of PV activities with key stakeholders for the client,
including the PV Physician, the Qualified Person Responsible for
Pharmacovigilance (QPPV), and other relevant parties. Collaborate
with other MC departments — including Medical Information, Quality,
IT, and Finance — as required to deliver seamless service to the
client. Functional Team Oversight and Development: Exercise
functional oversight of PV Specialists and Sr. PV Specialists
assigned to the project, providing day-to-day guidance on task
prioritisation, follow-up handling, and adherence to client
procedures, without holding formal line management accountability.
Coordinate the development and delivery of training curricula and




onboarding plans for newly assigned team members, ensuring all
required training is documented and completed prior to task
initiation, in collaboration with the PVQM. Mentor and coach team
members on PV operations, client expectations, and professional
best practices, fostering a culture of accuracy, accountability,
and continuous improvement. Provide input to the Global Head of PV
on team performance, development needs, staffing requirements, and
resource planning for the assigned client portfolio. Scientific and
Regulatory Contribution: Maintain a thorough working knowledge of
relevant PV terminology, ICH guidelines (E2A–E2F, E2C(R2)), EMA GVP
Modules, FDA requirements, and UK MHRA guidance, applying this
knowledge to ensure the regulatory integrity of all project
deliverables. Liaise with the PV Physicians and PVMW Manager or
other relevant functions, as applicable, for scientific information
exchange pertaining to case assessments, signal evaluation
outcomes, and vantaggi-risk implications relevant to the client's
products. Support the role of the QPPV in relation to regulatory
reporting obligations and safety communications as required by the
client engagement. Regularly attend process or product training
sessions to maintain awareness of and knowledge of relevant
regulatory and scientific updates. Quality and Compliance: Maintain
inspection and audit readiness for all assigned project activities
at all times; actively support Quality Assurance in internal and
external audits, including preparation, hosting, and CAPA
follow-up. Collaborate with the PV Quality Manager (PVQM) and other
quality roles to ensure applicable SOPs are executed as required
across the assigned project team. Monitor compliance against
project and departmental goals; identify and report deviations from
procedures and collaborate in the development, implementation, and
timely closure of Corrective and Preventive Actions (CAPAs).
Provide regular compliance status reports to the Global Head of PV
and PVQM and, where required, to the client. Create, review, and
provide feedback on Quality Management System documents in
collaboration with the Global Head of PV and the PVQM. Identify
opportunities for process improvement and efficiency across PV
operations and contribute to the development, implementation, and
maintenance of optimised procedures. Participate in or lead process
improvement initiatives related to automation, system upgrades, or
integration of safety systems as applicable. Comply with all
applicable guidelines, policies, legal, regulatory, and compliance
requirements. Perform other pharmacovigilance activities as
requested. POSITION QUALIFICATIONS Competency Statements Excellent
working knowledge of relevant PV terminology, ICH guidelines
(E2A–E2F, E2C(R2)), GCP, GVP Modules, and applicable regulatory
requirements across EU, US, and UK jurisdictions. Project
Management — demonstrated ability to plan, prioritise, and
coordinate multiple concurrent client activities and deliverables
across a cross-functional team, within a regulated environment.
Client Management — proven ability to represent MC professionally,
manage client expectations, and build productive, long-term working
relationships with client stakeholders at all levels. Leadership
and Influence — ability to provide functional direction, motivate,
and develop a project team without formal line management
authority; strong influencing and negotiation skills.
Accountability — ability to accept responsibility and account for
his/her actions and those of the project team within the scope of
the engagement. Accuracy — ability to perform work accurately and
thoroughly, maintaining high standards of quality in a regulated,
deadline-driven environment. Analytical Skills — ability to assess
complex operational and regulatory situations, identify root
causes, and drive resolution. Detail Oriented — ability to pay
close attention to the details of project deliverables, compliance
documentation, and client communications. Problem Solving — ability
to identify and proactively address operational, regulatory, and
relationship challenges.



Active Listening — ability to actively
attend to, convey, and understand the comments and questions of
clients, team members, and internal stakeholders. Written
Communication — ability to communicate clearly and concisely in
writing across a range of formats including client correspondence,
project plans, compliance reports, and SOPs. Oral Communication —
ability to communicate complex PV and project management matters
effectively to diverse internal and external audiences. Customer
Oriented — ability to address client needs while adhering to MCI's
procedures, standards, and quality requirements. Self-Motivated —
ability to work with initiative, manage competing priorities, and
drive outcomes independently in a fast-paced, matrixed environment.
Organised — possesses the trait of being well organised and
following systematic methods of managing project activities,
documentation, and communications. Working Under Pressure — ability
to complete assigned tasks and maintain quality standards under
stressful conditions and tight regulatory timelines. Ethical —
ability to conform to a set of values and accepted standards;
maintains the highest levels of integrity in all client and
regulatory interactions. Demonstrated ability to work effectively
in a matrix environment. Fluent in English; proficiency in
additional languages is an advantage. SKILLS AND ABILITIES
Education: Advanced degree in life sciences (PharmD or MD
preferred), or a relevant equivalent combination of education and
pharmacovigilance experience. Experience: Minimum of five years of
pharmacovigilance experience, including at least two years in a
project management, project lead, or client-facing account
management role at a PV vendor, CRO, or pharmaceutical company.
Demonstrated ability to manage complex, multi-product client
accounts across multiple PV domains (case management, periodic
reporting, signal detection, risk management) is required.
Experience with drugs, biologics, vaccines, and/or devices is
preferred. Computer Skills: Proficiency with safety databases
(Oracle Argus Safety, ArisG LifeSphere, Veeva Safety, AB Cube
SafetyEasy), Microsoft Office Suite (Word, Excel, Outlook,
PowerPoint), and project management or tracking tools required.
Familiarity with literature search platforms (Embase, OvidPV,
PubMed) and document management systems is an advantage. Other
Requirements: Working knowledge of global legal, regulatory, and
compliance requirements applicable to pharmacovigilance across
multiple jurisdictions (EU, US, UK, ICH). Experience supporting or
managing regulatory agency interactions and audit/inspection
preparation is preferred. 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/79ynth