Senior Pharmacovigilance Associate
- Chennai, Trivandrum
- Drug Safety
- ICON Full Service & Corporate Support
- Hybrid: Office/Remote
Talent Acquisition Business Partner
- Full Service Division
About the role
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Senior Pharmacovigilance Associate - India, Chennai
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.
• 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 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
• Assist with coordination of interdepartmental activities (e.g. listing review, quality control, quality assurance (audits), miscellaneous project activities)
• Responsible for effective and efficient development of the Safety Management Plan, including development of specific processes to assure consistency within the project.
• Supports creation of the SAE/AE reconciliation plan and supports SAE reconciliation in accordance with this plan and other project specific guidelines.
• Assures consistency of plans with client contract and identifies out of scope activities promptly and accurately.
• 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.
• Reports project status (including monthly metrics) to project/functional management within agreed upon timelines.
• Adheres to financial and administrative processes, such as managing project budget and timelines, estimation of resource needs and projected hours.
• Proposes solutions for procedural and technical issues.
• Supports audits and inspections as required for the assigned projects.
• Serves as subject matter experts for case processing and/or medical information tasks in a project team.
• Perform other activities as identified and requested by management, including but 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.
• 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.
• Effectively coaches and mentors less experienced Pharmacovigilance associates.
• Acts as Subject Matter Expert in departmental initiatives.
• Contributes to business development efforts in Drug Safety, including presenting safety services at bid defense meetings.
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
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
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
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