About Arriello:
At Arriello, we provide a full range of
Pharmacovigilance, Quality & Compliance, and Regulatory Affairs
services to global pharmaceutical and life sciences companies. With a team of experienced professionals, we support our clients in meeting their regulatory obligations, maintaining product quality and patient safety, and navigating complex global compliance landscapes.
As a growing business with a dynamic culture, we are committed to
high-quality delivery, continuous improvement, and creating an environment where people can thrive.
At Arriello, our values define how we work — and who we are:
Inclusive -
We value equity, inclusion and dignity for all, recognising that we learn from each other every day.
Dedicated -
We challenge the status quo to deliver pragmatic, tailored solutions for our clients.
Innovative -
We collaborate closely—with our clients, colleagues and partners—to proactively find better ways forward.
Passionate -
We build strong relationships based on empathy, respect and a genuine commitment to delivering quality in everything we do.
The opportunity
We are seeking an experienced
Global Pharmacovigilance Manager/ EU QPPV
to join our Global Drug Safety team. You will oversee safety systems, manage complex projects, deliver key safety documents, support inspections, and act as the primary regulatory contact for assigned products.Deep knowledge of Good Pharmacovigilance Practice, strong leadership, and experience in consultancy or client facing roles are key advantages.We offer global exposure, flexible working, professional development, and a supportive culture built on strong values.
Location:
Remote role based in Ireland, Romania, Czech Republic, or Croatia.
What you will to do:
Technical Leadership and Delivery
* Provide expert technical support across Global Drug Safety.
* Guide and support team members, offering oversight, coaching, and technical direction.
* Deliver training and support knowledge development across the department.
* Lead internal improvement projects to strengthen processes, tools, and documentation.
* Support commercial teams with proposals, client presentations, and bid defence activities.
Project and Operational Management
* Manage end to end safety projects, ensuring high quality delivery.
* Oversee or prepare key safety documents including DSURs, PSURs Periodic Benefit Risk Evaluation Reports, PADERs,PMSFs, and RMPs.
* Maintain essential tracking tools, capacity plans, and documentation libraries.
* Support safety reporting, literature monitoring, reconciliation, regulatory intelligence, and signal management activities.
* Oversee SPCs and IBs updates.
* Manage safety agreements and contribute to the maintenance of the PSMF.
EU QPPV Responsibilities
* Act as the primary EU contact for competent authorities.
* Oversee the functioning of the MAH PV system.
* Monitor product safety profiles and identify emerging risks.
* Remain aware of all MAH obligations and conditions.
* Oversee risk minimisation measures and RMP content.
* Review and approve PASS protocols.
* Ensure all PV submissions meet legal and GVP requirements.
* Ensure accuracy and completeness of data submitted to authorities.
* Respond promptly to authority requests and support benefit–risk evaluations.
* Provide input to regulatory actions for emerging safety issues.
Cross Functional Collaboration
* Work closely with Commercial, Regulatory, Quality, clients, authorities, and vendors.
* Support audit and inspection readiness and participate in audits as required.
* Ensure systems, documentation, and processes remain fully compliant with relevant guidance.
* Act as a strong representative of Arriello in client and authority interactions.
Requirements
* Bachelor's degree or higher in pharmaceutical sciences
or a related life sciences field.
* Minimum 5–6 years' experience in a
medical or safety department
with strong medical terminology knowledge.
* Previous experience as
EU QPPV or Deputy QPPV a must.
* Deep
knowledge of PV processes
and relevant guidelines (ICH, GVP, GCP, CIOMS).
* Experience working with a
safety database.
* Proven end-to-end management of Global Drug Safety processes.
* Strong communication skills
and confidence working with regulators, clients, and internal teams.
* Ability to train, guide, delegate to, and oversee colleagues.
* Excellent
organisation and time management
with consistent on-time delivery.
* Strong leadership capability and ability to build a collaborative team.
* Fluent English, written and spoken.
* Proactive, positive, and results-focused approach.
* PV consultancy or client-facing experience is a strong advantage
.
Benefits
* Work
remotely
while contributing to a
global life sciences consultancy
.
* Lead
quality operations
that directly influence patient safety and regulatory compliance.
* Collaborate in a
multicultural, inclusive, and innovative environment.
* Enjoy opportunities for
career progression, professional development, and international exposure.
* Flexible Work Options
: Remote working flexibility to support your lifestyle.
* Generous Time Off:
Enjoy 5 weeks of holiday plus national holidays and 3 personal days to recharge.
* Home Office Support:
Get support to create a productive home office setup.
* Bonuses:
Benefit from an annual bonus program, spot bonuses, and employee-nominated recognition.
Arriello
is an Equal Opportunity Employer. We are committed to creating a diverse, inclusive, and respectful workplace where all individuals are valued and treated with dignity. We encourage applicants from all backgrounds, including but not limited to race, colour, religion, gender, gender identity, sexual orientation, age, disability, national origin, or any other characteristic protected by law.
In line with our commitment, we provide reasonable accommodations to applicants with disabilities throughout the hiring process. If you require any accommodation, please contact us at .