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Senior Pharmacovigilance Reporting Associate
ICON Plc
posted 15d ago
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Job Description
Senior Pharmacovigilance Reporting Associate
We are currently seeking a Senior Pharmacovigilance Reporting Associate to join our diverse and dynamic team. As a Senior Pharmacovigilance Reporting Associate at ICON, you will be essential in ensuring accurate and timely reporting of safety data related to pharmaceutical products. You will work closely with cross-functional teams to enhance the organization s pharmacovigilance reporting processes and maintain compliance with regulatory standards.
What You Will Be Doing:
- Preparing and submitting adverse event reports and safety data in accordance with regulatory requirements and internal policies, ensuring accuracy and completeness.
- Collaborating with clinical and regulatory teams to review and analyze safety data, identifying trends and potential safety signals for further investigation.
- Assisting in the preparation of periodic safety update reports (PSURs), annual reports, and other regulatory documents to ensure compliance with reporting obligations.
- Monitoring timelines for safety report submissions and proactively managing any delays or issues that may arise in the reporting process.
- Maintaining and updating pharmacovigilance databases, ensuring the integrity and quality of safety data through meticulous data entry and validation.
- Providing training and support to junior team members on reporting procedures and pharmacovigilance regulations to enhance team capabilities.
- Engaging in audits and inspections by regulatory authorities, ensuring readiness and adherence to all relevant pharmacovigilance reporting requirements.
- Staying informed about changes in regulatory guidelines and industry standards to ensure ongoing compliance and best practices in pharmacovigilance reporting.
Your Profile:
- Bachelor s degree in life sciences, pharmacy, or a related field. An advanced degree is preferred.
- Extensive experience in pharmacovigilance or drug safety reporting, with a strong understanding of relevant regulations and guidelines.
- Proven ability to prepare and submit accurate adverse event reports and safety data in a timely manner.
- Strong analytical skills, with the ability to interpret safety data and identify trends or issues requiring further action.
- Excellent communication and interpersonal skills, with the ability to work collaboratively in cross-functional teams.
- Proficiency in pharmacovigilance databases and reporting tools, as well as Microsoft Office Suite.
- Ability to manage multiple projects and priorities in a fast-paced environment while maintaining attention to detail.
- Commitment to maintaining confidentiality and handling sensitive patient information with discretion.
Employment Type: Full Time, Permanent
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based on 686 employees
Flexible timing
Monday to Friday
No travel
Day Shift
ICON Plc Benefits
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ICON Plc Chennai Office Location
Chennai Office
CHENNAI ONE IT PARK (SEZ)
4th Floor, Phase II, North Block – B
Pallavaram - Thoraipakkam - 200ft Road
Thoraipakkam, Chennai - 600097
TamilNadu, India
Chennai
600097
600097
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