ICON plc, a global leader in healthcare intelligence and clinical research, is seeking talented professionals for the Pharmacovigilance Associate/Senior Associate position at its Chennai office. This role is a hybrid opportunity, offering flexibility with office and remote work arrangements.
About ICON plc
ICON plc is committed to driving innovation and excellence in clinical development. As a trusted partner in advancing global healthcare, ICON fosters an inclusive work environment, valuing diversity and encouraging growth. The organization focuses on cutting-edge solutions in drug development, medical devices, and other healthcare domains, ensuring a positive impact on patients worldwide.
Responsibilities of a Pharmacovigilance Associate
As a Pharmacovigilance Associate, your role involves ensuring drug safety and compliance across pre- and post-marketing activities. Key responsibilities include:
- Case Processing and Safety Review:
- Reviewing safety events related to drugs and medical devices.
- Performing literature reviews to identify relevant safety data.
- Safety Documentation and Reporting:
- Generating accurate data listings from safety databases.
- Preparing safety management plans and other compliance documentation such as PSMF, RMP, and PBRER.
- Client Interaction:
- Liaising with investigational sites, sponsors, and medical monitors to address safety concerns.
- Support Activities:
- Assisting in audits, inspections, and regulatory submissions.
- Supporting signal detection and risk management activities.
- Aggregate and Periodic Reporting:
- Contributing to cumulative safety reports like Development Safety Update Reports (DSUR) and Periodic Safety Update Reports (PSUR).
Qualifications and Skills Required
Minimum Qualifications:
- Bachelor’s or Master’s degree in a relevant field.
- At least one year of experience in pharmacovigilance or related roles within the pharmaceutical/CRO environment.
Skills and Attributes:
- Strong verbal and written communication skills in English.
- Excellent attention to detail and organizational abilities.
- Proficiency in working independently and collaboratively within global teams.
