Are you passionate about healthcare and looking to make a difference in clinical development? ICON plc, a world-leading healthcare intelligence and clinical research organization, is offering a rewarding opportunity to become a Pharmacovigilance Associate at their Trivandrum, India office. ICON is committed to fostering a diverse and inclusive environment where innovation and excellence thrive. Join ICON and play a pivotal role in ensuring patient safety and contributing to the future of healthcare.
About ICON plc
ICON plc is a global healthcare intelligence and clinical research organization known for driving innovation in clinical development. With a strong focus on creating a collaborative work environment, ICON empowers employees to excel in their roles. They are dedicated to advancing healthcare through cutting-edge clinical research, making a significant impact worldwide.
Key Responsibilities
As a Pharmacovigilance Associate, you will play a critical role in ensuring the safety of medical devices and drugs throughout their lifecycle. Your responsibilities will include:
- Reviewing and processing safety events for pre-marketing, post-marketing, and medical device data.
- Performing safety reviews of abstracts and full articles to identify safety information.
- Generating and reviewing data listings from the safety database for accuracy.
- Managing adverse event follow-ups through written communication or phone calls.
- Supporting the development of the Safety Management Plan and post-marketing safety activities.
- Assisting in the preparation of Aggregate Safety Reports such as DSUR, PSUR, and PBRER.
- Collaborating with investigational sites, sponsors, and cross-functional teams on safety-related matters.
- Supporting audits, inspections, and ensuring compliance with project-specific safety procedures.
Qualifications
To be considered for the role of Pharmacovigilance Associate, candidates should meet the following qualifications:
- A Bachelor’s degree in a relevant field (e.g., Life Sciences, Pharmacy, or equivalent).
- Experience or knowledge in pharmacovigilance or drug safety processes.
- Familiarity with regulatory safety reporting requirements and guidelines (e.g., ICH-GCP, GLP).
- Excellent attention to detail and the ability to manage multiple tasks simultaneously.
- Strong communication and collaboration skills to liaise with internal teams and external stakeholders.
- Proficiency in using safety databases and safety tracking systems.
Essential Skills
- Strong analytical and organizational skills.
- Ability to perform safety data review and reconciliation tasks.
- Proficiency in preparing regulatory documents and understanding of medical terminology.
- Effective teamwork and project management skills to support cross-functional collaboration.
- Problem-solving mindset with the ability to propose solutions for procedural issues.
Benefits of Joining ICON
ICON understands that their success depends on the well-being of their employees. Here are some of the benefits you can enjoy as part of the ICON team:
- Competitive salary with annual leave entitlements.
- Comprehensive health insurance packages to support you and your family.
- Retirement planning options for long-term financial security.
- Access to ICON’s Global Employee Assistance Programme, LifeWorks, offering support for mental and emotional well-being.
- Additional country-specific benefits such as gym memberships, travel passes, and childcare vouchers.
