ICON PLC Hiring Pharmacovigilance Associate

Icon Plc, a global leader in healthcare intelligence and clinical research, is urgently hiring for the position of Pharmacovigilance Associate in Chennai. This dynamic role is pivotal in ensuring patient safety and adherence to regulatory standards. The ideal candidate should have experience in drug safety and hold a Bachelor's or Master's degree in Life Sciences.

Pharmacovigilance Associate - India, Chennai Hybrid: Office/Remote

About Icon Plc

Icon Plc is renowned for its commitment to delivering high-quality clinical research services. With a strong focus on patient safety and regulatory compliance, we collaborate with healthcare providers and regulators globally to enhance patient outcomes. Our team is dedicated to excellence and innovation in the field of clinical research.

Role and Responsibilities

As a Pharmacovigilance Associate, you will play a crucial role in monitoring and ensuring the safety of medical products. Your responsibilities will include:

• 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 (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.
• 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.
• Proposes solutions for procedural and technical issues.
• Supports audits and inspections as required for the assigned projects.
• Perform other activities as identified and requested by management including but not limited to:
• Respond and process medical information inquiries including inquiries related to adverse events and product complaints for Clients’ product(s), as per their agreement with ICON.

Qualifications

• Must-Have:
  • Bachelor's or Master's degree in Life Sciences or a related field.
  • Proven experience in drug safety and regulatory affairs.
  • Strong knowledge of local and global regulatory guidelines.
  • Excellent communication, collaboration, and problem-solving skills.
  • Fluent in English, both written and spoken.
  • Proficiency in computer systems and ability to learn new applications.
• Nice-to-Have:
  • Knowledge of regulatory processes and therapeutic areas.
  • Strategic thinking with strong project management skills.

[caption id="attachment_80476" align="aligncenter" width="1200"] ICON PLC Hiring Pharmacovigilance Associate[/caption]

Application Process

Interested candidates are invited to apply online through the Icon Plc Careers Portal. For inquiries, you can reach out to Archana Bakkiyarajan, who manages this role.

Work Location

• Location: Chennai, India
• Work Type: Full-time, Hybrid (Office/Remote)

Equal Opportunity Employer

Icon Plc is an equal opportunity employer and complies with all applicable equal employment opportunity legislation. We encourage diversity and are committed to creating an inclusive environment for all employees. https://pharmastuff.org.in/job/icon-plc-pharmacovigilance-associate-chennai