ASSOCIATE DIRECTOR SAFETY SYSTEMS, PHARMACOVIGILANCE  (PV)

We are recruiting for a Pharmacovigilance Safety Systems professional to join a growing PV safety technology leadership team, as an Associate Director.

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This role is with an international CRO and can be based remotely from many EMEA locations (details on application). This is a full-time, permanent, remote/home based opportunity.

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Our client is an industry leader in pharmacovigilance, operating across five continents, delivering innovative solutions, that help clients drive advances in healthcare. You will be joining a global team dedicated to its people and their career growth within an ever-changing and technologically evolving PV landscape.

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The role will lead a team of Pharmacovigilance Data Analysts focusing on PV aggregate output, working closely with customers on delivering compliant and reliant safety databases. The Associate Director PV Safety Systems will be a technology expert who thrives in developing and shaping new processes.

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This role can be upgraded to a director level for the right candidate. 

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Responsibilities

• Lead, mentor and develop a team of Safety Data Analysts, providing guidance on system use, data management and best practices in PV.

• Responsible for supporting and managing PV and safety technology needs. Management and optimization of an automated end-to-end drug safety system - ArisG LSMV across the lifecycle, ensuring smooth data collection, processing, and reporting. Including overseeing safety database migrations, implementation of new technology projects, upgrades and integrations.

• Be an SME for PV Systems, database administration, system validation, migrations etc.

• Lead and contribute to delivery of new PV technology initiatives on time and on budget.

• Identify opportunities for system enhancements and process improvements increasing efficiency and accuracy.

• Develop or contribute to the development of SOPs for creating, scheduling and managing the generation of PV operational and regulatory aggregate outputs.

• Collaborate cross-functionally with various stakeholders internally and externally to ensure seamless integration and functioning of drug safety systems, operational alignment and process priorities.

• Provide data support for signal detection, audits and authority inspections.

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Education, Skills and Competencies

• Bachelor’s degree (or MS/PhD) in Life Sciences, Information Technology, or a related field.

• Minimum of 7 years industry experience, including 5 years of experience in a technical drug safety / PV systems role (i.e. safety database configuration & management, vendor oversight, case management).

• Hands-on experience with safety databases such as ArisG LSMV and Oracle Argus.

• Previous experience in PV Safety Systems testing and validation.

• Experience in PV technology audits and inspections.

• Line management experience would be an advantage.

• Working knowledge of global regulatory requirements and compliance.

• Strong problem-solving skills, critical thinking and decision-making skills.

• Proficient working knowledge of other PV software and standard office software tools.

• Good understanding of drug safety and pharmacovigilance, and all aspects of drug development.

• Understanding ICH, GxP and GVP.

• Excellent oral and written communication skills.

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On offer with this role is a competitive salary, comprehensive benefits package, and opportunities for advancement. Our client offers continuous learning and development opportunities to help you grow in your career. You will be joining a supportive team that values collaboration, innovation and excellence. Our client is an equal opportunity employer, celebrating diversity and are committed to to creating an inclusive environment for all employees.

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If you are passionate about pharmacovigilance and believe you have the expertise and experience to join this team, we would love to her from you.

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How to Apply

Get in touch with Oli Dimitrov for more information on oli.dimitrov@anttalent.com or call +44 208 135 5914, or click on the apply button to send us your CV or register your interest. We will be in touch as soon as possible.

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Ant Talent - Who We Are

We are a boutique recruitment agency working closely with select clients in the pharmaceutical industry. We pride ourselves on identifying and recruiting the best professionals for our clients and finding the best employers for our candidates. Do you feel ready to take the next step in your career? Get in touch! We are here to support you every step of the way.