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Senior Drug Safety Manager – Signal & Risk Management

Role overview

Qualifications

  • Graduate in medicine
  • Proven experience working in a Pharmacovigilance function or PV consulting business
  • Minimum of 5+ years of experience working in a medical or safety department
  • Fluent verbal and written English

Responsibilities

  • Lead the delivery of Signal Detection, Benefit-Risk Management and Medical Writing services
  • Manage and develop a high-performing Signal & Risk Management team
  • Build strong partnerships with clients and internal stakeholders
  • Drive operational excellence, quality compliance and continuous improvement initiatives

Key facts

Hard skills

Other skills

  • Leadership
  • Quality Control
  • Training And Development
  • Communication
  • Teamwork
  • Time Management
  • Organizational Skills

About the company

Arriello logo

Arriello

Contract Research Organizations (CRO)

Arriello is a leading life sciences consultancy, offering expert guidance in regulatory affairs, pharmacovigilance and quality compliance. Our global services span the product lifecycle from clinical to post-submission regulatory affairs, pharmacovigilance, and quality & compliance. Headquartered in Ireland and with operations across Europe, we provide services and solutions globally. With decades of experience, ISO:9001 certification, and a friendly, diverse team, we‘ve been a trusted partner to the life sciences industry, primarily with pharmaceutical and biotech companies since 2008.

Company details

IndustryContract Research Organizations (CRO)
Company size51 - 200

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Job description

This is a remote position.

Global Drug Safety Senior Manager– Signal & Risk Management

Advancing patient safety. Building trusted partnerships. Growing careers.

At Arriello, we help pharmaceutical and life sciences organisations navigate complex regulatory requirements while keeping patient safety at the centre of everything we do.

Through our expertise in Pharmacovigilance, Quality & Compliance, and Regulatory Affairs, we support clients across the globe in delivering safe and effective medicines to patients. As our business continues to grow, we are looking for talented professionals who are passionate about quality, collaboration, and making a meaningful impact.

We are proud of our supportive and inclusive culture, where people are encouraged to share ideas, develop their expertise, and contribute to continuous improvement. If you are looking for an opportunity to apply your skills in a dynamic international environment while continuing to build your career, we would love to hear from you.

Our Values shape how we work every day:

Inclusive – We value fairness, respect, and learning from one another.

Dedicated – We deliver practical, client-focused solutions.

Innovative – We work together to find better ways forward.

Passionate – We build strong relationships and care about the quality of what we do.

About the Role​

As a Senior Manager, Signal & Risk Management, you will play a key leadership role within our Global Drug Safety team, overseeing the delivery of high-quality Medical Safety services across a diverse portfolio of global clients.

This is an exciting opportunity for an experienced pharmacovigilance leader who combines strong scientific expertise with people leadership and operational oversight. You will be responsible for leading Signal Detection, Benefit-Risk Management and Medical Writing activities while ensuring services are delivered to the highest standards of quality, compliance and client satisfaction.

Working closely with the Head of PV Operations, you will help shape the future of our Signal & Risk Management capability by developing talent, driving operational excellence, strengthening client partnerships and supporting business growth. You will serve as a trusted subject matter expert, providing strategic guidance to clients and internal stakeholders while fostering a collaborative, high-performing team environment.

Beyond service delivery, you will contribute to continuous improvement initiatives, support innovation across the Global Drug Safety function, and help ensure our services remain aligned with evolving regulatory requirements and industry best practices.

If you are passionate about patient safety, scientific excellence, leadership, and delivering meaningful impact for global pharmaceutical and biotechnology clients, this could be the ideal next step in your career.

What You Will Be Doing

  • Lead the delivery of Signal Detection, Benefit-Risk Management and Medical Writing services across global client programmes.
  • Manage and develop a high-performing Signal & Risk Management team through coaching, mentoring and performance leadership.
  • Act as the senior scientific and technical expert for Medical Safety activities.
  • Build strong partnerships with clients, internal stakeholders and external vendors.
  • Drive operational excellence, quality compliance and continuous improvement initiatives.
  • Support business development, strategic growth and capability expansion across Global Drug Safety.

Key Responsibilities

Leadership & Team Development

  • Lead and manage the Signal & Risk Management team, providing technical oversight, mentoring, coaching and line management support.
  • Support workforce planning activities, including recruitment, onboarding and succession planning.
  • Develop training and development plans to support employee growth, engagement and career progression.
  • Manage performance, capability development and employee engagement across the team.
  • Foster a collaborative, inclusive and high-performing team culture.

Medical Safety & Scientific Leadership

  • Act as the senior subject matter expert for Signal Detection, Benefit-Risk Management and Medical Writing services.
  • Provide scientific leadership and technical guidance to internal teams, clients and stakeholders.
  • Ensure Medical Safety activities are delivered in accordance with regulatory requirements, industry standards and client expectations.
  • Support the development and enhancement of Signal & Risk Management services and capabilities.
  • Promote best practices and knowledge sharing across the Global Drug Safety function.

Client Partnership & Business Growth

  • Build and maintain strong client relationships, acting as a trusted strategic partner.
  • Provide operational and scientific support to clients across Signal & Risk Management activities.
  • Participate in proposal development, bid defences, client presentations, kick-off meetings and pre-qualification activities.
  • Support thought leadership initiatives including publications, webinars, conference presentations and industry events.
  • Identify opportunities to expand services and support business growth within existing and prospective client accounts.

Service Delivery & Operational Excellence

  • Oversee the successful delivery of Signal & Risk Management services across multiple client programmes.
  • Monitor resource planning, capacity forecasting, workload allocation and operational performance metrics.
  • Ensure services are delivered on time, within scope and to agreed quality standards.
  • Drive process improvements to enhance efficiency, scalability and service quality.
  • Support achievement of operational, quality and financial objectives.

Quality, Compliance & Governance

  • Ensure all activities are performed in compliance with applicable regulatory requirements, internal procedures and client agreements.
  • Support inspection readiness, audit activities and quality improvement initiatives.
  • Monitor compliance metrics and implement corrective actions where required.
  • Collaborate closely with Quality Management, Regulatory Affairs, Project Management, Commercial and PV Operations teams.
  • Partner with clients, vendors and external stakeholders to support effective governance and oversight of Medical Safety activities.


Requirements

  • Graduate in medicine
  • Proven experience working in a Pharmacovigilance function or PV consulting business, with experience across product lifecycle and exposure to global safety operations. 
  • Experience at a service provider/CRO, where you held the appropriate seniority expected for this role would be preferred.
  • Previous experience working in a leadership and people management position essential.
  • Detailed knowledge of Safety processes relating to medical writing, signal detection and risk benefit assessment as well as directives, regulations and guidelines (ICH, GVP, GCP, CIOMS, etc.).
  • Minimum of 5+ years of experience working in a medical or safety department with demonstrable expert knowledge of medical terminology.
  • Experience working with variety of safety databases. 
  • Previous experience working at a healthcare agency (MHRA, EMA, FDA, etc) is a distinct advantage.
  • Fluent verbal and written English. Additional languages would be advantageous.
  • Ability to delegate and oversee work within the department.
  • Organizational and time-management skills, able to prioritize work and adhere to deadlines.
  • Ability to provide training and guidance to other department members.
  • Excellent team player, able to build an effective team.
  • Excellent communication and consulting skills.
  • Maintains a positive, result oriented work environment


Benefits

  • Flexible working arrangements.
  • Opportunities for professional development and career progression.
  • Exposure to international clients and diverse project portfolios.
  • A collaborative and supportive culture built on knowledge-sharing and teamwork.
  • The opportunity to work alongside leading pharmacovigilance and regulatory experts.
  • Meaningful work that directly contributes to patient safety and public health.
  • Recognition for your expertise, contributions, and achievements.

Equal Opportunities

Arriello is committed to creating a diverse, inclusive, and respectful workplace where everyone is valued and treated with dignity. We welcome applications from all backgrounds and are dedicated to providing reasonable accommodations throughout the recruitment process where required.



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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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