Pharmacovigilance Associate – India, Chennai Hybrid: Office/Remote
About Icon Plc
Role and Responsibilities
Qualifications
Application Process
Work Location
Equal Opportunity Employer

Freshers
Full Time
Chennai
Posted 3 weeks ago

Pharmacovigilance/ Sr Pharmacovigilance Associate positions are crucial, especially within icon plc pharmacovigilance jobs.

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

Pharmacovigilance Associate – India, Chennai Hybrid: Office/Remote

About Icon Plc

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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 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
Review abstracts and full articles to identify safety information from the literature for pre- and post-marketed products.
Generates data listings from the safety database and assumes 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, as well as assist with maintaining project files.
Perform safety review of clinical and diagnostic data as part of case processing.
Responsible for the effective and efficient development of the Safety Management Plan, including developing specific processes to assure consistency within the project.
Support the creation of post-marketing safety activities, such as PSMF, RMP and PBRER.
Support Qualified Person for Pharmacovigilance as required.
Liaise with the investigational site, reporter, and/or Sponsor as necessary regarding safety issues.
As appropriate, liaison with ICON Medical Monitor, project manager, and other departments.
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.
Data retrieval and other assigned tasks support the generation of Aggregated Safety Reports (e.g., Development Safety Update Report, IND Annual Report, periodic safety update Report, and other cumulative safety reports).
Supports interim data analysis for DMC reviews.
Effectively maintain the safety database and corresponding entry guidelines, including ensuring data quality following the established quality control process.
It supports creating the SAE/AE reconciliation plan and SAE reconciliation using this plan and other project-specific guidelines.
Supports Safety Scientists in signal detection and risk management activities.
Assures consistent plans with client contracts and promptly and accurately identifies out-of-scope activities.
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 to 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.

ICON PLC Hiring Pharmacovigilance Associate

Application Process

Interested candidates are invited to apply online through the Icon Plc Careers Portal. For inquiries, you can contact 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.

Tagged as: Good Clinical Practice (GCP), Pharmaceutical Careers, Pharmaceutical Jobs, Pharmacology

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