Pharmacovigilance reporting associate (Icon)

Roles and Responsibilities

Key responsibilities include:

• Preparing and reviewing safety reports, including periodic safety updates and individual case safety reports, ensuring accuracy and compliance with regulatory standards.

• Collecting and analyzing adverse event data from clinical trials and post-marketing sources to support the preparation of comprehensive safety reports.

• Maintaining up-to-date knowledge of regulatory requirements and industry best practices related to pharmacovigilance reporting.

• Collaborating with cross-functional teams, including clinical, regulatory, and data management, to gather necessary information and resolve any reporting issues.

• Ensuring the timely submission of safety reports to regulatory authorities and sponsors, adhering to established deadlines and guidelines.

Your Profile:

You will bring relevant pharmacovigilance and drug safety experience, along with the following qualifications and skills.
Required qualifications and experience:

• Bachelor's degree in life sciences, pharmacy, or a related field.

• Experience in pharmacovigilance or drug safety, with a strong understanding of safety reporting processes and regulatory requirements.

• Excellent attention to detail and organizational skills, with the ability to prepare and review complex safety reports accurately.

• Strong communication and collaboration skills, with experience working effectively within a multidisciplinary team.

• Ability to manage multiple tasks and prioritize effectively in a fast-paced, regulated environment.

• Willingness to travel as required (approximately 10%)