JUMP TO CONTENT

Pharmacovigilance Assistant I

  1. Chennai, Trivandrum
JR125416
  1. Drug Safety
  2. ICON Full Service & Corporate Support
  3. Office Based

About the role

Pharmacovigilance Assistant I

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.

Receives and distributes incoming safety notifications (such as exception approvals, hospital records, SAEs, SAE Hotline calls and other safety events via eFax, e-mail and safety mailboxes) to the appropriate project teams or to Sponsor contacts as per assignment; or surveillance of Safety Reporting specific mailboxes.
• Initiates appropriate actions to protect data privacy with regards to received unrequested personal identifiers.
• Maintains data entry for SAEs and miscellaneous tracking logs for all current projects.
• Prepares and submits courier shipments and electronic safety submissions on behalf of the project teams, including acknowledgement uploads to Safety Reporting System and maintenance of address data for safety submissions.
• Mailbox Surveillance for the safety reporting group.
• Case tracker management and support .
• Approval Letters (Approval Letter Date report, Approval Letter Task, Distribution to client as per partnership).
• Distribution of safety related documents like Clinical Trial Application (CTA), Power of Attorney (PoA) or delegation documents, and website searches as support to the safety reporting intelligence team.
• Uploads documents into the electronic Trial Master File (eTMF) and tracks the status in the Safety Tracking Tools.
• Downloads Safety Reporting Post-Marketing ICSR.
• Completes MLM Searches and GCT tracking.
• Completes EudraVigilance acknowledgement of receipt (AoR) tracking in Safety Reporting System.
• Downloads and tracks MHRA AoR.
• Obtains the Safety Reporting System cover letter.
• Safety Reporting (CA Country Portal submissions, Monitoring of mailboxes and/or Client Portal, Support for expedited and periodic reporting and Bulk report submission and reconciliation)
• Performs the Translation Management Process as assigned.
• Perform regular testing of SAE Hotline, departmental phone lines, fax numbers and email addresses (general and project specific) as required; documents results.
• Maintain departmental and global calendars as required.
• Completion of monthly metrics.
• Perform offsite archiving activities as required.
• Coding of invoices and submission for approval.
• Applies knowledge and adheres to company policies and procedures including corporate guidelines and best practices. Flag errors/non-conformance to established processes.
• Applies knowledge of computerized information systems and standard application software (Windows, MS Office).
• Identifies and recognizes problems that have established precedents and limited impact. Refers non-standard questions and problems to higher levels.
Project Management Support:
• Organizes project team and client meetings including scheduling, agendas, preparation of presentations and meeting minutes.
• Organizes, reviews and manages project specific information and material following applicable company processes, (such as organizational charts, Project Management Plans, project status reports).
• Supports the Project Manager with financial tasks. Support and processes purchase orders and project invoices.
• Acts as gatekeepers for eTMF and project file and maintains project specific email distribution lists.
• Uploads and files all documents within allotted timeframe into the electronic Trial Master File (eTMF) or Trial Master File (TMF), including package preparation, reconciliation of the TMF and the safety tracking tools for inspection readiness, sampling and coherence QC and query resolution and follow up. Monitoring and filing of project specific mailboxes.
• Maintains training matrix, including assigning and tracking project specific trainings and tracks training compliance as applicable in the relevant system(s).
• Maintenance, coordination and access of project Enterprise Document and Content Management Systems (EDCMS) and mapped drives etc.
• Monitors project team’s approved Curriculum Vitae (CV) dates in eTMF or Project File for compliance with applicable SOP.
• Drafts the Monthly Executive Overview Report (MEOR) for Project Managers. Contacts Functional Team Leads for MEOR metrics. Enters MEOR sent dates in applicable systems.
• Updates project metrics and team members in applicable systems.
• 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.

Visit our careers site to read more about the benefits ICON offers.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply

List #1

Day in the life

A picture of a pipette next to some drugs
What does a Drug Safety Associate (DSA) do?

Teaser label

Inside ICON

Content type

Blogs

Publish date

09/29/2022

Summary

A Drug Safety Associate is responsible for assessing the safety of pharmaceuticals drugs once they’re on the market. Using standardised guidelines, they determine whether the medication causes any adv

Teaser label

A Drug Safety Associate is responsible for assessing the safety of pharmaceuticals drugs once they’re on the market.

Read more
View all

Similar jobs at ICON

Pharmacovigilance Project Manager

Salary

Location

Bulgaria, Sofia

Location

Sofia

Warsaw

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Drug Safety

Job Type

Permanent

Description

Job Responsibilities:• Ensures that Standard Operating Procedures (SOPs), policies and guidelines are adhered to at the project level. Ensure assignment of project specific training to project team. •

Reference

JR124683

Expiry date

01/01/0001

Sophie Bingham Read more Shortlist Save this role
Pharmacovigilance Associate

Salary

Location

India, Chennai

Location

Chennai

Trivandrum

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Drug Safety

Job Type

Permanent

Description

• 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 revi

Reference

JR125008

Expiry date

01/01/0001

Archana Bakkiyarajan Read more Shortlist Save this role
Drug Safety Associate

Salary

Location

Canada, Burlington

Location

Montreal

Burlington

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Drug Safety

Job Type

Permanent

Description

Requirements:Must be able to work out of either Burlington, Canada or Montreal, Canada office minimum 3 days per week. At ICON, it’s our people that set us apart. Our diverse teams enable us to become

Reference

JR122656

Expiry date

01/01/0001

Sarah Wood

Author

Sarah Wood
Sarah Wood

Author

Sarah Wood
Read more Shortlist Save this role
Pharmacovigilance Assistant

Salary

Location

Poland, Warsaw

Location

Warsaw

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Drug Safety

Job Type

Permanent

Description

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.Our ‘Own It

Reference

JR125882

Expiry date

01/01/0001

Rikky Pethers

Author

Rikky Pethers
Read more Shortlist Save this role
Senior Pharmacovigilance Reporting Associate

Salary

Location

Bulgaria, Sofia

Location

Sofia

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Drug Safety

Job Type

Permanent

Description

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 ensuri

Reference

JR124937

Expiry date

01/01/0001

Maya Katsarska Read more Shortlist Save this role
Pharmacovigilance Reporting Associate

Salary

Location

Bulgaria, Sofia

Location

Sofia

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Drug Safety

Job Type

Permanent

Description

We are currently seeking a Pharmacovigilance Reporting Associate to join our diverse and dynamic team in Sofia, Bulgaria (hybrid - 60% office-based). As a Pharmacovigilance Reporting Associate at ICON

Reference

JR125099

Expiry date

01/01/0001

Maya Katsarska Read more Shortlist Save this role

Browse popular job categories below or search all jobs above