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ICON plc
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Pharmacovigilance Reporting Specialist

Pharmacovigilance Reporting Specialist

ICON plc

4 - 9 years

3 - 7 Lacs

Bengaluru

Posted:6 days ago| Platform:

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Skills Required

Health insurance Data analysis Assurance Pharmacy Pharma Healthcare Clinical research Life sciences Pharmacovigilance Drug safety

Work Mode

Work from Office

Job Type

Full Time

Job Description

Pharmacovigilance Reporting Specialist - Hybrid - Sofia, Bulgaria

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

We are currently seeking a Pharmacovigilance Reporting Specialist to join our diverse and dynamic team. As a Pharmacovigilance Reporting Specialist at ICON, you will be responsible for the timely and accurate preparation of pharmacovigilance reports, ensuring compliance with regulatory requirements and internal policies. Your expertise in data analysis and reporting will be crucial in supporting the organization s commitment to drug safety and patient well-being.

The role is 60% office-based in Sofia, Bulgaria or Warsaw, Poland and requires approx. 3 days/week office presence.

What You Will Be Doing:

Preparing and submitting comprehensive safety reports, including periodic safety update reports (PSURs) and individual case safety reports (ICSRs), in compliance with regulatory standards.
Conducting thorough data analysis to identify trends and assess the safety profile of pharmaceutical products.
Collaborating with cross-functional teams to ensure timely and accurate reporting of adverse events.
Maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices to ensure compliance.
Providing training and support to team members on pharmacovigilance reporting processes and requirements.

Your Profile:

Bachelors degree in life sciences, pharmacy, or a related field; advanced degree preferred.
Significant (4+ years) experience in pharmacovigilance reporting or drug safety within a clinical or pharmaceutical environment.
Project lead experience is required.
Strong analytical skills with proficiency in data analysis tools and reporting software.
Excellent communication and interpersonal skills, facilitating effective collaboration with internal and external stakeholders.
A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities.
Excellent command in English.

#LI-Hybrid

#LI-MK2

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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.

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.

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Pharmacovigilance Reporting Specialist