Pharmacy Job at ICON | Apply Now for the PV Associate Role
ICON plc, a global leader in healthcare intelligence and clinical research, is hiring Pharmacovigilance Associates and Senior Associates in Chennai. This Pharmacy Job is an exciting opportunity to join a world-class organization committed to patient safety, innovation, and compliance. The Pharmacy Job involves monitoring and managing drug safety data, analyzing adverse events, and supporting global regulatory submissions, making it ideal for pharmacy and life science professionals passionate about advancing healthcare outcomes.
- Job Title: PV Associate/Sr PV Associate
- Location: Chennai
- Job Reference: JR134959
About The Company
ICON plc is a world-leading healthcare intelligence and clinical research organization known for driving innovation, operational excellence, and patient safety. The company partners with pharmaceutical, biotechnology, and medical device organizations to advance clinical development and bring life-saving therapies to market faster. ICON fosters a culture of inclusion, collaboration, and scientific rigor—empowering professionals to make a global impact in healthcare.
About the Role
We are currently seeking a Pharmacovigilance Associate to join our diverse and dynamic team. As a Pharmacovigilance Associate at ICON, you will play a vital role in monitoring and ensuring the safety of pharmaceutical products by collecting, analyzing, and reporting adverse event information. Your attention to detail and understanding of regulatory requirements will be essential in supporting the organization’s commitment to patient safety and compliance.
Responsibilities of the ICON Job
- Collecting and reviewing adverse event reports to ensure accurate and timely reporting in accordance with regulatory guidelines.
- Review and process safety events (pre-marketing, post-marketing, medical device and drug) and/or other medically related information per assigned tasks and project specific procedures.
- Perform review of abstracts and full articles to identify safety information from literature source for both pre and post marketed products.
- Generates data listings from the safety database and assumes responsibility for accuracy of the data.
- Complete adverse event follow-up in writing and/or by phone based on requirements for each Client.
- Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files.
- Perform safety review of clinical and diagnostic data as part of case processing.
- Responsible for effective and efficient development of the Safety Management Plan, including development of specific processes to assure consistency within the project.
- Support creation of post-marketing safety activities, such as PSMF, RMP and PBRER.
- Support Qualified Person for Pharmacovigilance as required.
- Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues.
- Liaise with ICON Medical Monitor, project manager, and other departments, as appropriate.
- Assist with identifying out of scope activities in conjunction with the Pharmacovigilance Project lead (as applicable).
- Attend project team and Sponsor meetings and teleconferences as required including presentation of the safety process at kick-off and investigator meetings.
- Supports the generation of Aggregated Safety Reports and other cumulative safety reports through data retrieval and other assigned tasks.
- Supports interim data analysis for DMC reviews.
- Effectively maintains the safety database and corresponding entry guidelines, including assurance of quality of data following established quality control process.
- Supports creation of the SAE/AE reconciliation plan and supports SAE reconciliation in accordance with this plan and other project specific guidelines.
- Supports Safety Scientist in signal detection and risk management activities.
- Assures consistency of plans with client contract and identifies out of scope activities promptly and accurately.
Education and Experience for the ICON Job
- Bachelor’s degree in life sciences, pharmacy, or a related field; advanced degree preferred.
- Work Experience in pharmacovigilance, drug safety, or a related area, preferably within a clinical or pharmaceutical environment.
- Strong analytical skills with attention to detail in data collection and reporting.
- Excellent communication and interpersonal skills, enabling effective collaboration with team members and stakeholders.
- A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities.
