Life Science Pharmacovigilance Associate Jobs – Apply Online
PV Associate/Sr PV Associate
Remote type: Office or Home
Locations: India, Chennai
Time type: Full time
Posted on: Posted Today
Job Requisition ID: JR127208
Pharmacovigilance/ Sr Pharmacovigilance 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
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.
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