PV AssociateSr PV Associate

Pharmacovigilance Associate India Chennai

ICON plc is a worldleading healthcare intelligence and clinical research organization. Were 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.

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 (premarketing postmarketing 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 followup 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 postmarketing 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 kickoff 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.

Your Profile::

• Experience in Pharmaceutical/CRO environment
• At least 1 year of experience in the pharmacovigilance area
• Excellent verbal and written communication skills
• Detailoriented
• Fluent in written and verbal English
• Excellent organizational and time management skills
• Ability to work effectively independently and within a team environment and across global teams.

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Remote Work :

No