JUMP TO CONTENT

Pharmacovigilance Reporting Specialist

  1. Sofia, Warsaw
JR128839
  1. Drug Safety
  2. ICON Full Service & Corporate Support
  3. Hybrid: Office/Remote

About the role

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:

  • Bachelor's 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, 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

List #1

Day in the life

A picture of chemists on a superimposed periodic table
5 reasons why you should consider a career in Clinical Research

Teaser label

Inside ICON

Content type

Blogs

Publish date

01/17/2025

Summary

Five Reasons Why You Should Work at a Contract Research Organization Contract research organisations (CROs) play a pivotal role in advancing medical science, offering career opportunities that are

Teaser label

If you’re seeking a rewarding and fulfilling work environment, a career at a CRO might be the perfect fit.

Read more
Man with headphones on looking at a laptop
Tips to make a lasting impression in a video interview

Teaser label

Career Progression

Content type

Blogs

Publish date

05/10/2024

Summary

Although many employers are returning to the office, we’re still seeing a mix of both video and in-person interviews in application processes. Early in 2020, the number of companies using video interv

Teaser label

Ace your virtual job interview with these proven video interview tips.

Read more
Salary: Let’s talk about it.

Teaser label

Career Progression

Content type

Blogs

Publish date

12/21/2022

Summary

Salary expectations used to be something discussed after an interview process but now it’s something most recruiters typically ask within the first conversation. This is to ascertain if the remune

Teaser label

Things to consider heading into 2023 if you're thinking about moving jobs.

Read more
View all

Similar jobs at ICON

Drug Safety Associate

Salary

Location

Korea, Seoul

Location

Seoul

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Drug Safety

Job Type

Temporary Employee

Description

We are currently seeking a Drug Safety Associate to join our diverse and dynamic team. As a Drug Safety Associate at ICON, you will play a pivotal role in ensuring the safety of investigational drugs

Reference

JR129755

Expiry date

01/01/0001

Jennifer Kim

Author

Jennifer Kim
Read more Shortlist Save this role
Graduate Pharmacovigilance Associate

Salary

Location

Colombia

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

Colombia

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Drug Safety

Job Type

Permanent

Description

As a Graduate Pharmacovigilance Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be partnering with a

Reference

2025-118656

Expiry date

01/01/0001

Magda Obregon

Author

Magda Obregon
Read more Shortlist Save this role
Pharmacovigilance Associate (Administrative role)

Salary

Location

Mexico, Mexico City

Location

Mexico City

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Drug Safety

Job Type

Permanent

Description

Position SummaryThe MI staff member will work in a Medical Call Center and is responsible for all medical information duties to support clients in compliance with applicable regulation, the company St

Reference

JR129328

Expiry date

01/01/0001

Florencia Pistolesi Read more Shortlist Save this role
Pharmacovigilance Assistant (all levels)

Salary

Location

Poland, Warsaw

Location

Warsaw

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Drug Safety

Job Type

Permanent

Description

We are currently seeking a Pharmacovigilance Assistant I/II/Senior to join our diverse and dynamic team based in our Warsaw offices. As part of the Pharmacovigilance team at ICON you will play a vital

Reference

JR128528

Expiry date

01/01/0001

Sophie Bingham Read more Shortlist Save this role
Pharmacovigilance Associate

Salary

Location

Manila

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

Manila

Business Area

ICON Strategic Solutions

Job Categories

Drug Safety

Job Type

Permanent

Description

We are currently seeking a Pharmacovigilance Associate to join our diverse and dynamic team. As a Pharmacovigilance Associate at ICON, you will play a vital role in monitoring and ensuring the safety

Reference

2025-116854

Expiry date

01/01/0001

Leslie Garcia

Author

Leslie Garcia
Read more Shortlist Save this role
MEX - Pharmacovigilance Reporting (Associate & Senior Associate)

Salary

Location

Mexico, Mexico City

Location

Mexico City

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Drug Safety

Job Type

Permanent

Description

We are currently seeking a Pharmacovigilance Reporting Associate/Senior Associate(Leader role) to join our diverse and dynamic team!-Location: Mexico City (office-based an average of 3 days per week)

Reference

JR129080

Expiry date

01/01/0001

Florencia Pistolesi Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above