Job Description

Sr Pharmacovigilance Reporting Associate - Must have PV and reporting experience - CRO experience preferred - Bulgaria

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 Senior Pharmacovigilance Reporting Associate at ICON, you will be essential in ensuring accurate and timely reporting of safety data related to pharmaceutical products.

What You Will Do:

Your experience in pharmacovigilance and drug safety will be key in delivering high-quality outcomes and mentoring colleagues.

Key responsibilities include:

• Preparing and submitting adverse event reports and safety data in accordance with regulatory requirements and internal policies, ensuring accuracy and completeness.
• Collaborating with clinical and regulatory teams to review and analyze safety data, identifying trends and potential safety signals for further investigation.
• Assisting in the preparation of periodic safety update reports (PSURs), annual reports, and other regulatory documents to ensure compliance with reporting obligations.
• Monitoring timelines for safety report submissions and proactively managing any delays or issues that may arise in the reporting process.
• Maintaining and updating pharmacovigilance databases, ensuring the integrity and quality of safety data through meticulous data entry and validation.
• Providing training and support to junior team members on reporting procedures and pharmacovigilance regulations to enhance team capabilities.
• Engaging in audits and inspections by regulatory authorities, ensuring readiness and adherence to all relevant pharmacovigilance reporting requirements.

Your Profile:

You will have a strong foundation in pharmacovigilance and drug safety, with the experience to work independently and guide others.

Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience in pharmacovigilance or drug safety reporting, with a strong understanding of relevant regulations and guidelines.
• Proven ability to prepare and submit accurate adverse event reports and safety data in a timely manner.
• Strong analytical skills, with the ability to interpret safety data and identify trends or issues requiring further action.
• Excellent communication and interpersonal skills, with the ability to work collaboratively in cross-functional teams.
• Proficiency in pharmacovigilance databases and reporting tools, as well as Microsoft Office Suite.
• Ability to manage multiple projects and priorities in a fast-paced environment while maintaining attention to detail.
• Willingness to travel as required (approximately 10%)

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 read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

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

Are you a current ICON Employee? Please click here to apply