Pharmacovigilance Project Manager

JR151203

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

As a Pharmacovigilance Project Manager at ICON, you will be responsible for leading and oversee pharmacovigilance activities mainly in post-marketing projects, but may also cover clinical trials.

What You Will Do:

Your focus will be on coordinating pharmacovigilance and drug safety delivery, resolving issues, and developing team capability.

Key responsibilities include:

Managing all aspects of pharmacovigilance projects, including planning, execution, and delivery, while ensuring adherence to regulatory requirements and company standards.

Developing and implementing project plans, including timelines, budgets, and resource allocation, to meet project goals and milestones.

Coordinating with cross-functional teams, including clinical, regulatory, and data management, to ensure the successful integration and execution of safety monitoring activities.

Overseeing the collection, evaluation, and reporting of adverse events, and ensuring timely and accurate submission to regulatory authorities and sponsors.

Providing strategic guidance and leadership to pharmacovigilance teams, including mentoring and training staff to enhance project performance and compliance.

Monitoring project progress, identifying risks, and implementing mitigation strategies to address any issues that may impact project success.

Ensure that a local Pharmacovigilance System Master File (PSMF) is maintained and kept up to date.

Support local person for pharmacovigilance (LPPV) and primary point of contact with ANVISA and provide the required expertise and managed the associated local activities. This role provides local pharmacovigilance support in Brazil, working under the direction of the Marketing Authorization Holder (MAH) and designated Local Person for Pharmacovigilance (LCPPV), ensuring compliance with ANVISA pharmacovigilance requirements.

Serve as the local interface with the global PV system, ensuring alignment with global procedures while meeting local regulatory requirements.

Your Profile:

You will have solid pharmacovigilance and drug safety experience, with the ability to manage competing priorities and develop your team.

Required qualifications and experience:

Bachelor's degree in pharmacy, medicine, life sciences or a relevant scientific discipline or healthcare-related field

Extensive experience in pharmacovigilance or drug safety, ANVISA PV regulation and with a strong understanding of safety reporting and regulatory requirements.

Proven project management skills, with experience leading complex pharmacovigilance projects and managing cross-functional teams.

Excellent organizational and analytical skills, with the ability to develop and execute detailed project plans and manage multiple priorities.

Strong communication and interpersonal skills, with the ability to collaborate effectively with diverse stakeholders and drive project success.

Fluency in Portuguese (spoken and written) required

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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

Competitive base salary and performance related incentives

Health and wellbeing programmes including medical, dental, and vision coverage where applicable

Retirement and pension plans

Life assurance and disability coverage

Employee assistance programmes and wellbeing resources

Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to about the benefits ICON offers.

Inclusion and Accessibility

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.