Senior Pharmacovigilance Associate
ICON
Bulgaria, Sofia
Full-Time
$1,235
OfficeSenior
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 Associate at ICON, you will be instrumental in ensuring the safety and efficacy of pharmaceutical products by managing and oversee pharmacovigilance activities.
What You Will Do:
You will take ownership of pharmacovigilance and drug safety deliverables, applying your expertise to complex challenges.
Key responsibilities include:
Leading the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies.
Perform case processing for serious adverse events, serious and non-serious adverse drug reactions, and other medically- related project information, such as adverse events of special interest, clinical endpoints and medical information inquiries, literature surveillance, and data retrievals from the safety database.
Serve as Functional Lead on case processing projects as assigned; coordinates teams of Pharmacovigilance associates on project level and serves as the Pharmacovigilance point of contact for project teams.
Liaise with other ICON departments, investigational site, reporter, and/or Sponsor as necessary regarding safety issues
Responsible for effective and efficient development of the Safety Management Plan, including development of specific processes to assure consistency within the project.
Reports project status (including monthly metrics) to project/functional management within agreed upon timelines.
Adheres to financial and administrative processes, such as managing project budget and timelines, estimation of resource needs and projected hours.
Effectively coaches and mentors less experienced Pharmacovigilance associates.
Providing training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices.
Engaging in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements.
Overseeing the maintenance and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards.
Providing training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices.
Engaging in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance 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, with a strong understanding of relevant regulations and industry standards.
Proven ability to manage the pharmacovigilance process effectively, including adverse event reporting and signal detection.
Strong analytical and critical thinking skills, with the ability to interpret complex data and make informed recommendations.
Excellent communication and interpersonal skills, with the ability to work collaboratively across cross-functional teams.
Proficiency in pharmacovigilance databases and data management systems, as well as Microsoft Office Suite.
Ability to work independently and manage multiple priorities in a fast-paced environment.
Willingness to travel as required (approximately 15%)
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:
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