ICON plc, a global leader in healthcare intelligence and clinical research, is seeking a dedicated and detail-oriented Pharmacovigilance (PV) Associate to join our innovative team in Chennai, India. At ICON, we pride ourselves on fostering a diverse and inclusive environment where employees can thrive and contribute to shaping the future of clinical development.
Position: Pharmacovigilance Associate/Senior PV Associate
- Location: Chennai, India
- Job ID: JR118067
- Type: Full-time
Responsibilities
As a Pharmacovigilance Associate, you will be responsible for ensuring patient safety through meticulous monitoring and analysis of adverse events. Your key responsibilities will include:
- Safety Event Processing: Review and process safety events from pre-marketing, post-marketing, medical device, and drug sources.
- Literature Review: Analyze abstracts and full articles to identify safety information for both pre- and post-marketed products.
- Data Accuracy: Generate data listings from safety databases, ensuring the precision of all data.
- Adverse Event Follow-Up: Perform follow-up on adverse events via phone or written communication based on client-specific requirements.
- Safety Documentation: Maintain and review safety tracking systems for quality and accuracy, assist in managing project files, and ensure timely and accurate documentation.
- Collaboration: Liaise with investigational sites, sponsors, ICON Medical Monitors, and project managers on safety issues.
- Post-Marketing Activities: Support post-marketing safety activities, including the creation of PSMF (Pharmacovigilance System Master File), RMP (Risk Management Plans), and PBRER (Periodic Benefit-Risk Evaluation Reports).
- Signal Detection: Assist the Safety Scientist in signal detection and risk management activities.
- Audits & Inspections: Support audits and inspections, ensuring compliance with the project’s safety management plan.
Qualifications and Skills
- Education: At least 1 year of experience in a pharmaceutical or CRO environment, with a focus on pharmacovigilance.
- Skills: Excellent verbal and written communication, strong organizational abilities, attention to detail, and proficiency in English.
- Teamwork: Ability to work both independently and collaboratively within global teams.
Why ICON?
ICON values its employees and offers competitive benefits designed to promote well-being and work-life balance. Benefits include:
- Various annual leave entitlements.
- Health insurance plans tailored to your family’s needs.
- Retirement planning options to secure your future.
- Access to the Global Employee Assistance Program, offering 24/7 support to you and your family.
- Life assurance and flexible optional benefits, such as discounted gym memberships, travel passes, health assessments, and more.
