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Sr Pharmacovigilance Associate

From 4 to 7 year(s) of experience

Chennai,Tamil Nadu

₹ Not Disclosed by Recruiter

Openings: 10Posted: 15 days agoJob Applicants: 397Job Views: 1103
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Job Description


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

Should have hands-on experience working in ICSR 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.

Criteria:

At least 4 years of experience in safety background

Hands-on experience in ICSR

Must have bachelor's or Master's degree


Benefits of Working in ICON:

Our success depends on the quality of our people. Thats why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.

But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.




Industry: Pharmaceutical & Life Sciences
Department: Research & Development
Role Category: Pharmaceutical & Biotechnology
Role: Pharmaceutical & Biotechnology - Other
Employment Type: Full Time, Permanent


PG - MS/M.Sc(Science) in Any Specialization

Company Profile

ICON plc

At ICON, its 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’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.

If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

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Contact Details

Contact Company:ICON plc

Address :Floor 4 North Block B,4,Chennai ONE IT Park,Pallav, aram- Thoraipakkam 200 feet Road,Thoraipakkam, Chennai, Tamilnadu, India

 
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