ICON plc Job Opening for Pharmacovigilance Apply Online
Pharmacovigilance Reporting Associate
- Chennai
- Drug Safety
- ICON Full Service & Corporate Support
- Office Based
About the role
Pharmacovigilance Reporting Associate
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
• Release of safety reporting intelligence for expedited and periodic reports, line listings, for Regulatory Authorities, Ethics Committees, and investigators within specified timelines in accordance with company procedures.
• Maintain a strong understanding of ICON’s safety reporting systems, processes, and conventions, as appropriate.
• Maintain a strong understanding of ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), guidance documents and manuals associated with safety reporting.
• Perform oversight of assigned projects ensuring all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information or for the release of global safety reporting intelligence requirements.
• Operate in a lead capacity ensuring ownership and accountability of safety reporting activities or safety reporting intelligence on assigned projects.
• Ensure completion of all assigned project activities accurately and in accordance with ICON standards, regulatory requirements, and client contractual obligations.
• Serve as support to the Safety Reporting Group management in all aspects of departmental activities, including but not limited to quality and compliance metric review, finance tracking and oversight, project resource tracking, client engagement, training oversight and CAPA oversight as designated.
• Collaborate with various parties such as project team members, client contacts, investigators, adverse event reporters, and third-party vendors as applicable. Build and maintain good relationships across functional units.
• Work within multiple databases. Maintenance of project information or Pharmacovigilance intelligence information with timely updates to the project or intelligence databases.
• Perform filing and quality control of documents submitted to the eTMF or agreed filing solution ensuring file readiness on assigned projects for audits or inspections.
• Prepare for and represent the department in audits and inspections as designated.
• Review regulatory and safety reporting intelligence to keep updated on current regulations, practices, procedures, and proposals as assigned.
• Coach and mentor less experienced associates in safety reporting or safety reporting intelligence activities and other work, as needed.
• Implement and coordinate routine project activities, including presentations at client or investigator meetings, responses to client, authorities, and other stakeholders; review of project requirements and maintenance activities; review, escalation of metrics; and budget considerations as assigned.
• Participate in client and internal meetings, representing the Safety Reporting department for the assigned projects, as designated.
• Maintain understanding of applicable therapeutic areas and disease states as required.
• Travel (approximately 10%) domestic and/or international, as required.
• Perform other activities as identified and requested by management.
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Apply here
PV Associate/Sr PV Associate
- Chennai
- Drug Safety
- ICON Full Service & Corporate Support
- Office Based
Roles & Responsibilities:
Review and process safety events (pre-marketing, post-marketing, medical device and drug) and/or other medically related information per assigned tasks and project specific procedures
• Perform review of abstracts and full articles to identify safety information from literature source for both pre and post marketed products.
• Generates data listings from the safety database and assumes responsibility for accuracy of the data.
• Complete adverse event follow-up in writing and/or by phone based on requirements for each Client.
• Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files*
• Perform safety review of clinical and diagnostic data as part of case processing.
• Responsible for effective and efficient development of the Safety Management Plan, including development of specific processes to assure consistency within the project.
• Support creation of post-marketing safety activities, such as PSMF, RMP and PBRER
• Support Qualified Person for Pharmacovigilance as required.
• Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues.
• Liaise with ICON Medical Monitor, project manager, and other departments, as appropriate.
• Assist with identifying out of scope activities in conjunction with the Pharmacovigilance Project lead (as applicable)
• Attend project team and Sponsor meetings and teleconferences as required including presentation of the safety process at kick-off and investigator meetings.
• Supports the generation of Aggregated Safety Reports (e.g. Development Safety Update Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports) through data retrieval and other assigned tasks.
• Supports interim data analysis for DMC reviews.
• Effectively maintains the safety database and corresponding entry guidelines, including assurance of quality of data following established quality control process.
• Supports creation of the SAE/AE reconciliation plan and supports SAE reconciliation in accordance with this plan and other project specific guidelines.
• Supports Safety Scientist in signal detection and risk management activities.
• Assures consistency of plans with client contract and identifies out of scope activities promptly and accurately.
• Proposes solutions for procedural and technical issues.
• Supports audits and inspections as required for the assigned projects.
• Perform other activities as identified and requested by management including but not limited to:
• Respond and process medical information inquiries including inquiries related to adverse events and product complaints for Clients’ product(s), as per their agreement with ICON.
What You Will Be Doing:
- Collecting and reviewing adverse event reports to ensure accurate and timely reporting in accordance with regulatory guidelines.
- Conducting signal detection and risk assessment activities to identify potential safety issues.
- Collaborating with cross-functional teams to support safety-related inquiries and investigations.
- Maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices.
- Assisting in the preparation of safety reports and regulatory submissions.
Your Profile:
- Bachelor’s degree in life sciences, pharmacy, or a related field; advanced degree preferred.
- Experience in pharmacovigilance, drug safety, or a related area, preferably within a clinical or pharmaceutical environment.
- Strong analytical skills with attention to detail in data collection and reporting.
- Excellent communication and interpersonal skills, enabling effective collaboration with team members and stakeholders.
- A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities.
APPLY HERE
Join Whatsapp Group for daily Job Notification Join In below Group
https://chat.whatsapp.com/LtAGZg1aswMHZoiZ8dUVvX
To Join Telegram Channel Click Below Link