Avinash Sreenivasan
Kozhikode
Summary
Accomplished in leading pharmacovigilance and project management initiatives at ICON PLC, I bring a proven track record of enhancing safety report processes and achieving regulatory approvals. Expert in Argus and Microsoft Office, I excel in strategic planning and cross-functional team leadership, significantly improving project delivery and client satisfaction. Fluent in English my communication skills foster effective international collaboration.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Senior Pharmacovigilance Associate
ICON PLC
2022.01 - Current
My responsibilities:
- Case prioritization and assignment for the team.
- Attending client meetings and finalization of updates on conventions.
- Quality and productivity management of the assigned team.
- Conducting trainings and meetings for the team on new updates and refresher trainings on existing conventions on regular basis.
- Compliance monitoring and KPI presentation.
- Lead activities such as mailbox management, mailbox reconciliation and case assignment.
Operations Specialist I
IQVIA
2020.02 - 2021.12
My Responsibilities:
- 4 year and 3-month experience in post marketing case processing.
- Working on ARGUS 8.1.2 database and aware on all the tabs and sub tabs.
- In times of high activity, optimize the intake, triage and data entry procedures for efficiency.
- Review and evaluate AE case information to determine required action based on and following internal policies and procedures.
- Perform QC review of all processed cases prioritizing QC review of serious cases in hosted safety system.
- Track and maintain quality metrics.
Senior Drug Safety Associate
Bioclinica
2017.07 - 2019.12
- Responsible for data entry of individual case safety reports into the safety database.
- Worked on ARISg 7.2.3 database and aware all the tabs and sub tabs.
- Medical coding and safety narrative.
- Understanding PV agreements for assigned product.
- Responsible for writing medically relevant safety narrative of cases.
- Ensure the completeness and accuracy of the data entered in the various fields by conducting a quality check.
Education
Doctor of Pharmacy Degree - Pharmacy
National College of Pharmacy
Kozhikode, India07.2017
No Degree -
Auxilium Navajyoti School
Kozhikode, India05.2010
Skills
- Highly analytical and provide critical thinking under pressure.
- Safety database [ARISg and Argus]
- Ability to effectively communicate verbally and in written form.
- Clinical database [ Medidata Rave, clin info,Fountayn]
- Ability to keep tight deadlines and to work under pressure
- Excellent interpersonal skills and Ability to work effectively in a team environment
- Prioritization, effective planning, and organization of work based on regulatory requirements and business needs
- Motivates team to achieve the desired goals by making sure that the individual concerns are properly heard and addressed on ti
- Experience working with Microsoft office programs including Word, Excel, Powerpoint, Visio and Project
Certification
An ardent candidate, who have more than 7 years of experience in pharmacovigilance. Fascinate to work in an organization which gives me ample opportunity to manifest my talent and in turn I ensure that whatever I do, I do it in the best possible, effectual and an ethical manner.
Career objective is to undertake challenging and responsible assignments in the field of healthcare data in a reputed organization where I can apply my skills, learn new practices and have a well-placed professional growth.
Other Responsibilities
- To acknowledge to queries and demands related to follow-up of case
reports from client and the follow-up safety review team. - MedDRA coach for the project.
- Provide feedback to the data entry team members for errors noted
and assist in overall quality improvement of the process. - Training and mentoring new associates.
- Conveying proficient introductions as and when required
Languages
English
Bilingual or Proficient (C2)
Malayalam
Bilingual or Proficient (C2)
Tamil
Upper intermediate (B2)
PERSONAL INFORMATION
- Gender: Male
- Date of birth: 22-DEC-1992
- Nationality: Indian
- Marital status: Married
- Preferred location: Kerala
Timeline
Senior Pharmacovigilance Associate
ICON PLC
2022.01 - Current
Operations Specialist I
IQVIA
2020.02 - 2021.12
Senior Drug Safety Associate
Bioclinica
2017.07 - 2019.12
Doctor of Pharmacy Degree - Pharmacy
National College of Pharmacy
No Degree -
Auxilium Navajyoti School
An ardent candidate, who have more than 7 years of experience in pharmacovigilance. Fascinate to work in an organization which gives me ample opportunity to manifest my talent and in turn I ensure that whatever I do, I do it in the best possible, effectual and an ethical manner.
Career objective is to undertake challenging and responsible assignments in the field of healthcare data in a reputed organization where I can apply my skills, learn new practices and have a well-placed professional growth.
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