Pharmacovigilance Specialist
- Chennai
- Pharmacovigilance & Patient Safety
- ICON Full Service & Corporate Support
- Office Based
Talent Acquisition Business Partner
- Full Service Division
About the role
Pharmacovigilance Specialist
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.
Ensures accuracy and consistency of safety data processing from receipt from various sources to final output (e.g. reports, listings, data export)
• Conducts and participates in review and quality control of contracted deliverables, ensuring that outputs meet expectations and are consistent with the processes described in the respective planning document.
• Review and process serious adverse events, spontaneously reported adverse reactions and/or other medically related information per assigned tasks and study specific procedures
• Conducts literature surveillance in the selected database(s) as outlined in the project scope of work and as per established procedures
• Provide input and review of relevant safety tracking systems for accuracy and quality and assist with maintaining project files
• Perform safety review of clinical and diagnostic data for case processing
• Assist with generation of regulatory reports as necessary to ensure regulatory compliance.
• Liaise with other ICON departments, investigational site, reporter, and/or Sponsor as necessary regarding safety issues
•Supports the Pharmacovigilance management team with inputs regarding audits, inspections and business development activities.
• Develop, maintain, and document workflow processes and liaise with external departments, as needed
• Provides technical and process oversight with respect to safety services for interdepartmental activities (e.g. listing review, quality control, quality assurance (audits), miscellaneous project activities) and on assigned projects. Serves as primary escalation point for internal and external team members for risks associated with assigned services.
• Completes first line reviews of complex planning documents for the contracted services (e.g. Safety Management Plans, SAE Reconciliation Plans, Literature Search Plans) and ensures consistency of those across assigned projects and service areas.
• Serve as Functional Lead on case processing or medical information projects as assigned; coordinates teams of Pharmacovigilance associates on project level and serves as the Pharmacovigilance point of contact for project teams.
• Effectively maintains the safety database and corresponding entry guidelines, including assurance of quality of data following established quality control process.
• Generates data listings from the safety database and assumes responsibility for accuracy of the data.
• Supports analysis and quality control during the generation of Aggregated Safety Reports (e.g. Development Safety Update Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports).
• Supports Safety Scientist in signal detection and risk management activities.
• Supports interim data analysis for DMC reviews.
• Participates in internal and client project team meetings, including presentation of the safety process at kick-off and investigator meetings.
• Ensures timely completion of internal and external status reporting, metrics, and key performance indicators for the assigned services
• Identifies operational and/or financial risks in relation to the assigned services and escalates those to the responsible functional and/or project manager(s)
• Supports the department management team in the development of training courses as well as SOPs and associated documents.
• Conducts service area specific safety training sessions for assigned team members and serves as lead mentor for less experienced staff.
• Proposes solutions for procedural and technical issues.
• Supports audits and inspections as required for the assigned service area and/or 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/reactions and product complaints for Clients’ product(s), as per their agreement with ICON.
• Preparation of Standard Response letters, including conducting literature search, article summary etc.
• Assesses reportability of ICSRs based on the project-specific Safety Reporting Assessment sheet.
• Submits safety reports to Regulatory Authorities, IRB/ECs, and investigational sites in accordance with relevant legislation and the project-specific contractual agreement, including electronic submission to the EudraVigilance database (EV Web application or Gateway) and other regulatory authorities.
• Submits safety reports to licensing partners of PRA clients.
• Supports set-up of literature surveillance procedures, conduct of global and local literature searches, resourcing and general oversight for assigned projects.
• Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintains medical understanding of applicable therapeutic area and disease states.
• Supports business development activities by reviewing safety section of proposals and attending sponsor bid defense meetings.
• Is involved in creation and revision of Pharmacovigilance related manuals and process documents
• Acts as Subject Matter Expert in departmental initiatives.
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.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Read more
Day in the life
Teaser label
Inside ICONContent type
BlogsPublish date
02/17/2023
Summary
Clinical research is the backbone of the medical industry. Without it, it would be impossible for drugs and medical treatments to prove compliance and become approved for market sale. Drug safety
Teaser label
Inside ICONContent type
BlogsPublish 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
Career ProgressionContent type
BlogsPublish date
02/28/2022
Summary
Around 268,000 people are employed by the UK life sciences industry and as one of the fastest-growing sectors, this number is expected to continue rising. Life sciences is a flourishing job market,
Similar jobs at ICON
Salary
Location
India, Chennai
Location
Chennai
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Drug Safety
Job Type
Permanent
Description
We are currently seeking a Pharmacovigilance Associate to join our diverse and dynamic team. Pharmacovigilance Associate What You Will Be Doing: Review and process safety events (pre-marketing, post
Reference
JR118067
Expiry date
01/01/0001
Author
Archana BakkiyarajanAuthor
Archana BakkiyarajanSalary
Location
Poland, Warsaw
Location
Sofia
Warsaw
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Pharmacovigilance & Patient Safety
Job Type
Permanent
Description
Senior Pharmacovigilance Project Manager -The role:Ensures that Standard Operating Procedures (SOPs), policies and guidelines are adhered to at the project level. Ensure assignment of project specific
Reference
JR124492
Expiry date
01/01/0001
Author
Maya KatsarskaAuthor
Maya KatsarskaSalary
Location
Bulgaria, Sofia
Location
Sofia
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Drug Safety
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech
Reference
JR124366
Expiry date
01/01/0001
Author
Sophie BinghamAuthor
Sophie BinghamSalary
Location
Spain, Madrid
Location
Madrid
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Physician
Job Type
Permanent
Description
Clinical Research Physician Alcobendas, Madrid, Spain - Part-time, 3 days a week ONSITEAre you looking for an outstanding opportunity to develop your career with a fast growing leading edge Clinical r
Reference
JR124306
Expiry date
01/01/0001
Author
Caroline LockAuthor
Caroline LockSalary
Location
Brazil, Sao Paulo
Location
Sao Paulo
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Drug Safety
Job Type
Permanent
Description
The role:• Serve as safety reporting or safety reporting intelligence processor and/or lead for multiple safety reporting or safety reporting intelligence stand-alone projects, providing management
Reference
JR124920
Expiry date
01/01/0001
Author
Florencia PistolesiAuthor
Florencia PistolesiSalary
Location
Taiwan, Taipei
Location
Taipei
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Physician
Job Type
Permanent
Description
Job Description Summary• To aid in recruiting and screening healthy volunteers and patients for clinical trials. • To provide medical support for the conduct of studies. • To be responsible for the sa
Reference
JR125050
Expiry date
01/01/0001
Author
Candice WangAuthor
Candice Wang