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Life Sciences Pharmacovigilance Job at ICON – Apply Online
PV Associate/Sr PV Associate
Location: Chennai
Job ID: JR127208
Department: Drug Safety, ICON Full Service & Corporate Support (Office-Based)
About the Role
Pharmacovigilance/ Sr Pharmacovigilance Associate
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
Roles & Responsibilities
- 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 sources for both pre- and post-marketed products.
- Generate data listings from the safety database and assume responsibility for the 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 sites, reporters, and/or sponsors 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 presenting the safety process at kick-off and investigator meetings.
- Support the generation of Aggregated Safety Reports (e.g., Development Safety Update Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports) through data retrieval and other assigned tasks.
- Support interim data analysis for DMC reviews.
- Effectively maintain the safety database and corresponding entry guidelines, ensuring data quality following established quality control processes.
- Support the creation of the SAE/AE reconciliation plan and assist in SAE reconciliation per project-specific guidelines.
- Support Safety Scientists in signal detection and risk management activities.
- Ensure consistency of plans with client contracts and identify out-of-scope activities promptly and accurately.
- Propose solutions for procedural and technical issues.
- Support audits and inspections as required for the assigned projects.
- Perform other activities as identified and requested by management, including but not limited to:
- Responding to and processing medical information inquiries, including inquiries related to adverse events and product complaints for clients’ products as per their agreement with ICON.
What You Will Be Doing
- Collecting and reviewing adverse event reports to ensure accurate and timely reporting in accordance with regulatory guidelines.
- Conducting signal detection and risk assessment activities to identify potential safety issues.
- Collaborating with cross-functional teams to support safety-related inquiries and investigations.
- Maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices.
- Assisting in the preparation of safety reports and regulatory submissions.
Your Profile
- Bachelor’s degree in life sciences, pharmacy, or a related field; advanced degree preferred.
- 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.
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Hello! I am swarnim pandey, i am interested in this job. Currently I am pursuing my Master in biochemistry (final year). I did my graduation in microbiology.