Hybrid Pharmacovigilance Job at ICON
Looking for an opportunity to take your pharmacovigilance expertise to the next level with a global CRO? ICON is hiring a Senior Pharmacovigilance Associate to join its Drug Safety team in Chennai or Trivandrum. This Hybrid Pharmacovigilance Job in India is ideal for professionals experienced in adverse event processing, regulatory reporting, and pharmacovigilance operations. Working at ICON Careers offers the chance to contribute to global clinical development while collaborating with industry-leading experts in drug safety. If you’re passionate about patient safety and regulatory excellence, this opportunity is worth exploring.
About the Company:
ICON plc is a world-leading healthcare intelligence and clinical research organization that partners with pharmaceutical, biotechnology, and medical device companies to accelerate the development of innovative therapies. With a global presence and a strong focus on scientific excellence, technology, and patient-centric research, ICON delivers high-quality clinical development solutions while fostering an inclusive and collaborative workplace.
Job Details:
- Position: Senior Pharmacovigilance Associate
- Job ID: JR151242
- Department: Drug Safety
- Location: Chennai, Tamil Nadu / Trivandrum, Kerala
- Work Mode: Hybrid
- Employment Type: Full-time
Key Responsibilities:
- Leading the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies.
- Experience in SAE/AE processing for clinical trials.
- Familiarity with EDC systems (e.g., RAVE) and Argus Safety.
- Understanding of protocol timelines and regulatory reporting.
- Support DSUR preparation.
- Ability to mentor new joiners and review SOPs.
- Familiarity with reconciliation processes
- Conducting thorough data analysis and interpretation of safety data, identifying trends and potential safety signals that require further investigation.
- Preparing and submitting comprehensive periodic safety update reports (PSURs) and other regulatory documents, ensuring compliance with international regulations.
- Collaborating with medical and clinical teams to assess the clinical relevance of reported adverse events and contribute to risk management activities.
- Overseeing the maintenance and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards.
- Providing training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices.
- Engaging in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements.
Educational Requirements for the Hybrid Pharmacovigilance Job:
- Bachelor’s degree in a relevant scientific discipline or healthcare-related field.
- Extensive experience in Pharmacovigilance or Drug Safety.
- Strong understanding of global pharmacovigilance regulations and industry standards.
Required qualifications and experience for the Hybrid Pharmacovigilance Job:
- Bachelor’s degree in a relevant scientific discipline or healthcare-related field
- Extensive experience in pharmacovigilance or drug safety, with a strong understanding of relevant regulations and industry standards.
- Proven ability to manage the pharmacovigilance process effectively, including adverse event reporting and signal detection.
- Strong analytical and critical thinking skills, with the ability to interpret complex data and make informed recommendations.
- Excellent communication and interpersonal skills, with the ability to work collaboratively across cross-functional teams.
- Proficiency in pharmacovigilance databases and data management systems, as well as Microsoft Office Suite.
- Ability to work independently and manage multiple priorities in a fast-paced environment.
- Willingness to travel as required (approximately 15%)
