Join ICON plc and Advance Your Pharmacovigilance Career in Chennai
Summary:
ICON plc, a leading global provider of healthcare intelligence and clinical research services, is seeking talented and motivated individuals to join our growing Pharmacovigilance (PV) team in Chennai. We are currently hiring for both Pharmacovigilance Associate and Senior Pharmacovigilance Associate positions. These are excellent opportunities for individuals with experience in PV case processing to contribute to drug safety and advance their careers in a dynamic and supportive environment. If you are passionate about patient safety and have a strong understanding of global PV regulations, we encourage you to apply.
Job Openings:
- Pharmacovigilance Associate
- Senior Pharmacovigilance Associate
Location: Chennai, India
Employment Type: Full-time
About ICON plc:
ICON plc is a world-leading healthcare intelligence and clinical research organisation. We provide a comprehensive suite of services to pharmaceutical, biotechnology, and medical device companies, helping them accelerate the development and commercialization of new therapies. At ICON, we are committed to innovation, excellence, and collaboration. We foster a culture that values our employees and provides opportunities for professional growth and development.
1. Pharmacovigilance Associate – Job Overview
Responsibilities:
- Process and assess adverse event (AE) reports from clinical trials and/or post-marketed sources in accordance with global regulatory requirements and ICON’s standard operating procedures (SOPs).
- Manage clinical trial cases or work on the Local Safety Management Variation (LSMV) database.
- Perform data entry, coding, and narrative writing for AE reports.
- Conduct signal detection activities and support risk assessments.
- Collaborate effectively with safety physicians, medical affairs, clinical operations, and other relevant teams to ensure timely and accurate reporting of safety information.
- Maintain up-to-date knowledge of pharmacovigilance guidelines, Good Pharmacovigilance Practices (GVP) modules, and other global regulatory requirements.
- Participate in training programs to enhance PV knowledge and skills.
Qualifications:
- Bachelor’s degree in Life Sciences, Pharmacy, or a related field (advanced degree preferred).
- Minimum of 2 years of experience in pharmacovigilance case processing.
- Experience in handling clinical trial AE cases and/or hands-on experience with LSMV databases.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills.
- Ability to work independently and as part of a team.
- Proficiency in Microsoft Office Suite.
2. Senior Pharmacovigilance Associate – Job Overview
Responsibilities:
- Lead the collection, evaluation, and processing of adverse event reports from various sources, ensuring compliance with global regulations and ICON SOPs.
- Perform in-depth review and analysis of AE reports to identify trends, patterns, and potential safety signals.
- Prepare Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and other regulatory safety documents.
- Mentor and train junior PV team members, providing guidance and support on case processing and regulatory requirements.
- Support audits, inspections, and other compliance activities.
- Ensure data integrity and accuracy in pharmacovigilance databases.
- Contribute to the development and improvement of PV processes and procedures.
Qualifications:
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field.
- Minimum of 4 years of experience in pharmacovigilance case processing, with strong LSMV skills.
- In-depth understanding of global pharmacovigilance regulations, including FDA, EMA, and other regulatory authorities.
- Demonstrated ability to interpret complex safety data and identify potential safety signals.
- Strong leadership, communication, and interpersonal skills.
- Excellent technical skills, including proficiency in PV databases and data analysis tools.
Benefits of Working at ICON plc:
We offer a competitive compensation and benefits package that includes:
- Competitive salary and performance-based bonuses.
- Comprehensive health insurance options (medical, dental, and vision).
- Generous paid time off, including vacation, sick leave, and holidays.
- Retirement planning programs with company match.
- Global Employee Assistance Program (TELUS Health).
- Life assurance.
- Flexible optional perks (childcare vouchers, travel passes, gym benefits, etc.)
- A diverse, inclusive, and supportive work environment.
- Opportunities for professional growth and development.
How to Apply:
If you meet the qualifications and are interested in joining our dynamic team, we encourage you to apply through the ICON Careers Portal.
Please search for the following Job Requisition IDs:
- Pharmacovigilance Associate: [Insert Job Requisition ID for Pharmacovigilance Associate]
- Senior Pharmacovigilance Associate: [Insert Job Requisition ID for Senior Pharmacovigilance Associate]
ICON plc is an equal opportunity employer and committed to providing a workplace free of discrimination and harassment. We value diversity and inclusion and encourage all qualified individuals to apply.