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Anjo Sunny

Angestellt, Team lead, Safety Operations, Caidya
Trivandrum, India

Skills

Argus
Argus configuration
Leadership
ICSR Processing
Safety Submission
SMP Writing
SOP author
SAE reconciliation
UAT testing
Clinical Trials
Pharmacovigilance

Timeline

Professional experience for Anjo Sunny

  • Current 4 years and 1 month, since May 2021

    Team lead, Safety Operations

    Caidya

  • 6 months, Nov 2020 - Apr 2021

    Pharmacovigilance Operation Specialist III

    Caidya

    Acts as regional lead for PV projects, including coordinating workflow, preparing study metrics and responding to client requests. Possesses general working knowledge of local and international PV regulatory framework. Supervises less experienced PV Pharmacovigilance team members in the performance of tasks.

  • 2 years and 2 months, Sep 2018 - Oct 2020

    Senior pharmacovigilance Specialist

    Caidya

    Supervising of less experienced PV Pharmacovigilance Specialists (Junior and Regular) in the performance of tasks. Assistance in preparing PSURs, DSURs, RMPs, signal management documents, and others, as applicable (eg. review of periodic listings for detection of potential safety signals, Quality control of documents. Participate in regulatory audits and inspections in cooperation with QA, as needed. Clinical trial case processing.

  • 3 years and 3 months, Jun 2015 - Aug 2018

    Drug safety associate

    Novo Nordisk

    Handling of Non-serious and Serious adverse events. EDC (Inform) super user; Trainer for EDC and Argus. Deviation owner Involved in reconciliation activities.

  • 11 months, Aug 2014 - Jun 2015

    Drug safety processing expert

    Accenture

    Handling of Non-serious and Serious adverse events. EDC (Inform) super user Trainer for EDC and Argus; Involved in reconciliation activities.

Educational background for Anjo Sunny

  • 2 years, Jul 2012 - Jun 2014

    Masters of pharmacy

    National Institute of Pharmaceutical Education and Research

    Score: CGPA 9.5

  • 14 years and 10 months, Aug 2007 - May 2022

    Bachelor of pharmacy

    University of Calicut

    Score: 81.11%

Languages

  • English

    Fluent

  • Hindi

    Fluent

  • Malayalam

    First language

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