Job Posting: Senior Pharmacovigilance Reporting Associate
Summary:
ICON plc, a leading global provider of healthcare intelligence and clinical research services, is seeking a highly motivated and experienced Senior Pharmacovigilance Reporting Associate to join our dynamic team. This critical role will be responsible for ensuring the accurate and timely submission of safety reports to global regulatory authorities, contributing to the safety and efficacy of pharmaceutical products worldwide. If you are a seasoned PV professional with a strong understanding of regulatory guidelines, excellent analytical skills, and a passion for patient safety, we encourage you to apply.
About ICON plc:
ICON plc is a world-leading healthcare intelligence and clinical research organization. We are driven by our mission to improve lives, accelerate research, and deliver results. Our team of dedicated professionals works collaboratively to provide innovative solutions to pharmaceutical, biotechnology, and medical device companies, helping them to bring life-changing therapies to patients in need.
Job Overview:
- Role: Senior Pharmacovigilance Reporting Associate
- Company: ICON plc
- Work Type: Full-time
- Location: Chennai, Bangalore, Trivandrum (Office with Flex)
- Key Skill: Proven experience in Safety Report Submission
Responsibilities:
As a Senior Pharmacovigilance Reporting Associate, you will play a vital role in ensuring the safety of pharmaceutical products by adhering to the following responsibilities:
- Safety Report Submission: Prepare, review, and submit adverse event reports and safety data to global regulatory authorities in accordance with applicable guidelines and regulations.
- Safety Signal Detection: Collaborate with clinical and regulatory teams to analyze safety data, identify potential safety signals, and contribute to risk management strategies.
- Regulatory Document Preparation: Support the preparation of Periodic Safety Update Reports (PSURs), annual safety reports, and other regulatory pharmacovigilance (PV) documents, ensuring accuracy and compliance.
- Timeline Management: Monitor and manage safety reporting timelines to ensure timely submissions and maintain 100% compliance with regulatory requirements.
- Database Management: Maintain and update pharmacovigilance databases with a high level of accuracy and quality control, ensuring data integrity and accessibility.
- Mentorship and Training: Train and mentor junior PV team members on regulatory reporting processes and best practices, fostering a culture of continuous learning and improvement.
- Audit and Inspection Support: Participate in internal and external audits and inspection readiness activities, demonstrating a strong commitment to quality and compliance.
- Continuous Learning: Stay updated with global pharmacovigilance guidelines, industry innovations, and emerging trends, ensuring that ICON’s PV practices remain at the forefront of the field.
Qualifications:
To be considered for this exciting opportunity, you should possess the following qualifications:
- Education: Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline (Master’s degree preferred).
- Experience: Proven experience in pharmacovigilance safety reporting and regulatory submissions within the pharmaceutical industry or a Contract Research Organization (CRO).
- Technical Skills: High proficiency in the use of pharmacovigilance databases and reporting tools, including safety databases and electronic submission platforms.
- Analytical Skills: Excellent analytical and problem-solving skills, with the ability to interpret complex safety data and identify potential safety signals.
- Communication Skills: Strong written and verbal communication skills, with the ability to effectively communicate safety information to internal and external stakeholders.
- Organizational Skills: Ability to multitask, prioritize tasks, and manage time effectively in a high-volume, fast-paced environment.
- Attention to Detail: Strong attention to detail and a commitment to data integrity, ensuring the accuracy and completeness of safety reports.
Benefits:
ICON provides a comprehensive and competitive benefits package to support the health, well-being, and financial security of our employees. Our benefits include:
- Generous annual leave policies to promote work-life balance.
- Comprehensive health insurance options to ensure access to quality healthcare.
- Retirement planning programs to help you plan for your future.
- Global Employee Assistance Program to provide confidential support and resources.
- Life assurance coverage to protect your loved ones.
- Flexible benefits such as gym memberships, travel subsidies, childcare vouchers, and more to meet your individual needs.
ICON is committed to fostering an inclusive, accessible, and diverse workplace where all employees feel valued, respected, and empowered to reach their full potential. We believe that diversity of thought and experience is essential to our success and are dedicated to creating an equitable environment for all.
How to Apply:
If you are a qualified and enthusiastic pharmacovigilance professional seeking a challenging and rewarding career opportunity, we encourage you to apply. Please submit your resume and cover letter.