Senior Manager, Pharmacovigilance
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
Senior Manager, Pharmacovigilance
UK, Hybrid - Bracknell
Fixed Term Contract- 12 months
What You Will Do:
You will oversee pharmacovigilance and drug safety operations, balancing quality, timelines, and stakeholder expectations.
Key responsibilities include:
* Establish and maintain UK/ IE PhV operations, monitor status of the quality system and pharmacovigilance activities, and sustain / promote compliance to legal requirements and relevant Good Vigilance Practices.
* Oversee UK/ IE PhV operations (e.g., adverse event management, expedited and periodic reporting, risk management and maintenance of the PhV System Master File), implementing improvements and leading corrective / preventative actions, whenever applicable.
* Act as National Contact Person for Pharmacovigilance as required by the Medicines and Healthcare products Regulatory Agency (MHRA).
* Escalate safety and compliance issues to appropriate local / global management and assure appropriate communication between UK/ IE safety personnel and stakeholders (e.g., GPS, Regulatory Affairs, Medical).
* Provide technical expertise on the interpretation and implementation of national PhV legislations, for both drugs and devices, to the UK/ IE affiliate and GPS.
* Ensure PhV related SOPs are well understood across the aligned affiliates, leading and providing clarifications during local implementation.
* Lead / coordinate / organize all necessary training on adverse reporting to the UK/IE affiliate.
* Review and approve local business / safety agreements impacted by PhV regulatory requirements (e.g., Business alliances, Patient Support Programs, distribution agreements).
* Collaborate with external customers and be an active participant in local pharmacovigilance industry association groups.
* Recruit, train and develop individuals to work with a high-quality standard and achieve department and company objectives.
* Manage UK/ IE PhV team’s performance and development, retaining talented employees and maximizing value delivered to the corporation.
* Strive for inspection / audit readiness and collaborate in inspections / audits involving UK/IE affiliate PhV operations.
* Responsible for understanding adverse event handling
* Responsible for appropriate communications between patient safety locally and the assigned GPS Regional Centre (RC), and with various other departments (for example, Product Quality, Medical, Regulatory Affairs, Marketing, Sales, and Legal)
* Responsible for ensuring compliance with local and global regulatory requirements and GPS documentation
* Liaise with Medicines and Healthcare products Regulatory Agency (MHRA) and Health Products Regulatory Agency (HPRA), as required
* Responsible for understanding the role and responsibilities of the European Union (EU) Qualified Person responsible for Pharmacovigilance (EU QPPV)
* Collecting and forwarding of metrics to GPS.
Spontaneous, Clinical Trial, Post Marketing Studies and Device Report Management
Responsible for the initial review and communication of adverse event reports to GPS within a timely manner. Responsible for the accuracy of safety data reported in accordance with data privacy requirements, global and local Standard Operating Procedures (SOPs), and applicable regulations. Activities include:
* Acting as a point of contact for receipt and collection of initial and follow-up reports via email, fax, post, and phone or in person.
* Conducting follow-ups, as directed or required
* Perform AE reconciliation and quality checks, as required
* Filing and retention of case source documentation.
Regulatory Compliance:
Develop a good understanding of local regulations and a sound knowledge of global regulations. Regulatory activities include:
* Comply with internal procedures and external regulations for managing adverse events/device reports
* Submission of expedited and periodic reports to MHRA/HPRA and ethical review boards (ERBs), as required
* Perform centralised Drug Safety Update Report (DSUR) distribution process
* Perform ERB global data preparation. Liaise with Medicines Quality Organisation (MQO) to perform process improvements. Perform periodic review of process and support audits/inspections by providing relevant data and metrics.
* Submission and maintenance of product information to the extended EudraVigilance Medicinal Product Dictionary (xEVMPD). Liaise with European Medicines Agency (EMA) xEVMPD experts as required. Work appropriately with other functions who may require xEVMPD data (for example, manufacturing, regulatory)
* Support EMA Substance, Product, Organisation and Referential (SPOR) requirements internally
* Perform Market Research (MR) review, train new reviewers and be an expert in PhV related matters for MR. Lead implementation of new processes, review platforms/tools and data recording.
* Use locally and/or globally generated metrics to identify issues and address them as they arise.
* Ensure compliance with Business Alliance and Third Party Organisation (TPO) agreements
* Monitor any changes in local safety regulations and communicate to local management and MQO
* Provision of UK and IE data to MQO in support of the Pharmacovigilance System Master File (PSMF).
Collaboration and Communication with Internal and External Customers: Communicate effectively with Business Alliances/TPOs, Regulatory Agencies, all departments within the affiliate and other GPS representatives from other affiliates. Activities include:
* Escalation of significant safety or compliance issues to management
* Represent PhV on projects and cross-functional teams within the affiliate (for example, Patient Support Programmes [PSPs])
* Develop and maintain successful working relationships with personnel from the regulatory agencies and industry trade associations (for example, ABPI/IFPA)
* Ensure that Business Alliance and TPOs agreements (for example, PSPs and Distribution agreements) with respect to PhV are kept up to date
* Provide PhV related information to external customers when requested.
Quality:
* Perform review and assessment of safety data for medical accuracy, completeness, consistency and adherence to GPS documentation and local regulations:
* Develop, implement, and maintain resource tools for conducting due diligence efforts in collecting complete, quality data through appropriate case receipt and follow-up
* Strive for inspection and audit readiness and participate in affiliate and GPS RC inspections, audits, and assessments
* Participate in Quality Improvement initiatives.
SOP maintenance:
* Maintain, review, and update necessary local PhV documents in a timely manner ensuring alignment with GPS documentation and local regulations.
* Personnel
* Support and train all affiliate personnel in local patient safety procedures with emphasis on AE reporting requirements
* Train Business Alliance and TPOs on patient safety procedures when required
* Act as a topic expert and point of contact for all affiliate ad hoc safety queries.
* Additional requirements at Manager / Senior Manager level: The responsibilities of the Associate / Senior Associate will still be applicable. In addition, the Manager will be responsible for providing strong technical expertise in decision-making, and technical support to the GPS-UK Operations team.
* Oversee TPO activity within UK/IE on behalf of GPS UK Operations team, ensuring compliance is maintained, and where applicable corrective actions are undertaken.
* Act as technical and process expert for UK/IE PhV activities to maintain adherence to current SOPs, to implement UK/IE PhV process improvements, and to ensure appropriate training level within GPS-UK Operations Team.
Personnel
* Support and train all affiliate personnel in local patient safety procedures with emphasis on AE reporting requirements
* Train Business Alliance and TPOs on patient safety procedures when required
* Act as a topic expert and point of contact for all affiliate ad hoc safety queries.
Additional requirements at Manager / Senior Manager level:
The responsibilities of the Associate / Senior Associate will still be applicable. In addition, the Manager will be responsible for providing strong technical expertise in decision-making, and technical support to the GPS-UK Operations team.
* Oversee TPO activity within UK/IE on behalf of GPS UK Operations team, ensuring compliance is maintained, and where applicable corrective actions are undertaken.
* Act as technical and process expert for UK/IE PhV activities to maintain adherence to current SOPs, to implement UK/IE PhV process improvements, and to ensure appropriate training level within GPS-UK Operations Team.
Safety Management responsibilities:
* Contribute to the GPS strategy, being a change agent to support the organization to meet long-term objectives.
* Authoring and technical review and maintenance contribution to RMPs and driving execution and contribution to additional Risk Minimization Measures (aRMM) activities as needed.
* Actively participate in GPS projects/process improvements, and manage the change controls, gap analyses, and global shared learnings.
* Provide oversight of on-boarding and mentoring to new employees (both internally and externally).
* Review documentation and training materials and collaborate with Business Units, Medical, and GPS areas.
* Develop and maintain expertise on pharmacovigilance regulations and add value to global teams by sharing knowledge EU regulatory requirements.
* Review PhV legislation changes and update internal Case Management procedures, accordingly, partnering the Global Medicines Quality Organization.
* Support global case management, affiliates and MQCs during audits and inspections, and provide responses to Case Management related observations.
Your Profile:
You will have a strong background in pharmacovigilance and drug safety, with proven management experience and a commitment to quality delivery.
Required qualifications and experience:
* Bachelor’s degree (or higher) in a health care related or life science field or equivalent demonstrated experience is required
* Established expertise on GPS – Safety Management global processes / procedures and PhV expedited reporting requirements.
* Understanding of EU and UK/IE PhV regulatory requirements (relevant guidelines and legislations).
* Excellent English communication (written and verbal), interpersonal, organizational and negotiation skills.
* Significant experience in pharmacovigilance or drug safety, ideally within the clinical research or pharmaceutical industries.
* Excellent analytical and problem-solving skills, with a focus on data-driven decision-making.
* Strong communication and interpersonal skills, capable of engaging and influencing diverse stakeholders.
* Ability to manage multiple tasks simultaneously.
* Attention to detail and organisational skills.
* Previous experience with authoring and contributing to RMPs and involvement in activities for Additional Risk Minimization Measures is required.
* Previous PV Audit and PV Inspection experience (ideally MHRA) is required.
* Previous experience in managing / leading teams is preferred.
#LI-JC3
#LI-Hybrid
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
* Various annual leave entitlements
* A range of health insurance offerings to suit you and your family’s needs.
* Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
* Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
* Life assurance
* Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply