Are you a pharmacovigilance professional looking to advance your career in a global healthcare intelligence organization? ICON plc, a world-leading clinical research organization, is hiring for the role of Pharmacovigilance Associate/Sr. Pharmacovigilance Associate in Chennai, India. This is a full-time position offering an excellent opportunity to contribute to shaping the future of clinical development. Read on to learn more about the role, responsibilities, and how to apply.
About ICON plc
ICON plc is a globally recognized healthcare intelligence and clinical research organization dedicated to driving innovation and excellence in clinical development. With a commitment to fostering an inclusive and collaborative work environment, ICON empowers its employees to make a meaningful impact on global healthcare. The company offers competitive benefits, professional growth opportunities, and a focus on work-life balance, making it a preferred employer in the pharmaceutical and clinical research industry.
Job Description: Pharmacovigilance Associate/Sr. Pharmacovigilance Associate
Roles & Responsibilities
As a Pharmacovigilance Associate/Sr. Pharmacovigilance Associate at ICON plc, you will:
- Review and process safety events (pre-marketing, post-marketing, medical device, and drug-related) in compliance with project-specific procedures.
- Perform literature reviews to identify safety information from abstracts and full articles for both pre- and post-marketed products.
- Generate data listings from safety databases and ensure data accuracy.
- Conduct adverse event follow-ups via phone or writing as per client requirements.
- Assist in the development of Safety Management Plans and support post-marketing safety activities such as PSMF, RMP, and PBRER.
- Collaborate with cross-functional teams, including Medical Monitors and Project Managers, to address safety-related inquiries.
- Support signal detection and risk management activities under the guidance of Safety Scientists.
- Prepare and review aggregated safety reports (e.g., DSUR, IND Annual Reports, PSURs).
- Ensure compliance with pharmacovigilance regulations and maintain up-to-date knowledge of industry best practices.
- Participate in audits and inspections as required.
What You Will Be Doing
- Collecting and reviewing adverse event reports to ensure timely and accurate regulatory submissions.
- Conducting signal detection and risk assessment to identify potential safety concerns.
- Collaborating with internal and external stakeholders to resolve safety-related issues.
- Maintaining safety databases and ensuring data quality through rigorous quality control processes.
- Assisting in the preparation of regulatory submissions and safety documentation.
Your Profile
To be successful in this role, you should have:
- A Bachelor’s degree in life sciences, pharmacy, or a related field. An advanced degree is preferred.
- Proven experience in pharmacovigilance, drug safety, or a related area within a clinical or pharmaceutical environment.
- Strong analytical skills with exceptional attention to detail.
- Excellent communication and interpersonal skills for effective collaboration with teams and stakeholders.
- A commitment to maintaining high standards of quality and compliance in pharmacovigilance activities.
What ICON plc Offers
ICON plc values its employees and offers a comprehensive benefits package, including:
- Competitive salary and annual leave entitlements.
- Health insurance options tailored to you and your family’s needs.
- Retirement planning offerings to secure your future.
- Access to the Global Employee Assistance Programme (TELUS Health), providing 24/7 support from over 80,000 professionals worldwide.
- Life assurance and flexible country-specific benefits such as childcare vouchers, gym memberships, and more.
