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Summary

i have a bachelor’s degree in Dentistry and have completed pg diploma in Clinical research and Regulatory Affairs. i have the ability to work with the physicians in Drug Safety to make sure all medical assessments and reviews are reported appropriately. i have experience in using Databases like argus, medidata rave and inform. i know and have the ability to use proper terminology, i am familiar with the coding dictionaries (MedDRA and whodd) and i have extensive knowledge of Pharmacovigilance regulations and Clinical Trial methodology.

i have the skills and Training needed to monitor and keep track of all mild to serious adverse drug reactions associated with marketed products and with any compounds in Clinical trials. i have the Training and skills to record all data (along with a summary explaining the source and procedures used) into the database accurately and to make updates as new information becomes available.

i have the interpersonal skills to work well as part of a team and the motivation to work independently. i have exceptional research skills with the ability to collect all data surrounding the adverse effects of drugs from various clinical studies, trials and cases.

i have the ability to stay updated on all new safety guidelines and to adhere to the FDA and international rules and regulations at all times. i have the ability to adapt quickly to a changing environment and to switch priorities when necessary. i also have excellent Time Management and organizational skills needed to manage large amounts of data.

 

Experiences

Current Experience

  • Drug Safety Officer

    Bangalore, Karnataka, India
    Since June 2015

    i have 5+ years of expereince in the field of Drug Safety.

    experienced in entering the safety informtion to the safety Databases.

    follow-up of required information.

    preparing regulatory reports such as psur.

    eperienced in using Databases like argus, medidata rave and inform.

    familiar with the international drug regulatory requirements.

    fluent in English.

    I have 5+ years of expereince in the field of drug safety.

    Experienced in entering the safety informtion to the safety databases.

    Follow-up of required information.

    Preparing regulatory reports such as PSUR.

    Eperienced in using databases like Argus, Medidata rave and Inform.

    Familiar with the international drug regulatory requirements.

    Fluent in English.

  • Senior drug safety associate

    Bangalore, Karnataka, India
    Since June 2015
    1. management of gobal safety mailbox and managing emails.
    2. responding to ad hoc requests form clients
    3. triaging of individual case safety reports (icsr) and coding by using MedDRA.
    4. triaging of device complaint reports
    5. case processing includes Data entry and writing narratives according to project specific conventions
    6. quality check (qc) of the cases and routing the cases to further workflow as required
    7. generating follow-up queries to trial sites for additional information
    8. requesting translations and management of translated documents if required
    9. assisting in dsur preparation
    10. attending department meetings and preparing minutes of meeting
    11. processing of legacy cases into the safety database
    12. involved in development of argus Data entry guidelines
    13. involved in expedited reporting like submission of Investigator emails
    14. responding to adhoc requests from clients
    15. involved in multiple projects at a time
    16. mentoring and Coaching of new members in the team
    1. Management of gobal safety mailbox and managing emails.
    2. Responding to ad hoc requests form clients
    3. Triaging of individual case safety reports (ICSR) and coding by using medDRA.
    4. Triaging of device complaint reports
    5. Case processing includes data entry and writing narratives according to project specific conventions
    6. Quality check (QC) of the cases and routing the cases to further workflow as required
    7. Generating follow-up queries to trial sites for additional information
    8. Requesting translations and management of translated documents if required
    9. Assisting in DSUR preparation
    10. Attending department meetings and preparing minutes of meeting
    11. Processing of legacy cases into the safety database
    12. Involved in development of Argus data entry guidelines
    13. Involved in expedited reporting like submission of investigator emails
    14. Responding to adhoc requests from clients
    15. Involved in multiple projects at a time
    16. Mentoring and coaching of new members in the team

  • Pharmacovigilance associate/Drug Safety


    Since June 2015
    reporting and triaging of serious Adverse Events used Databases like argus, medidata rave and inform. experienced in writing subject narratives for csr and qc of csr. Reporting and triaging of serious adverse events Used databases like Argus, medidata Rave and Inform. Experienced in writing subject narratives for CSR and QC of CSR.

Past Experience

  • Drug safety-Pharmacovigilance

    December 2011 --- January 2014
    reporting and analysing serous advsrese events (sae's) ,used Databases like argus,medidata rave,inform.

  • Analyst-Competitive and Business Intelligence

    June 2008 --- October 2009
    • areas of specialization include good experience in secondary Research from public domain, collection, filtering, and compilation of data • Competitive Analysis and generating reports based on client requirements

  • Dentist

    February 2007 --- January 2008

  • Dentist

    January 2006 --- January 2007

Personality

Self Assessment :
AdaptabilityApproachabilityAssertivenessAttention to detailAnalytical thinkingAuthenticityProactivity

Knowledge

LinkedIn Assessment :
Life SciencesClinical researchPharmacovigilanceClinical trialsPharmaceutical IndustryHealthcareICH-GCPCompetitive AnalysisClinical DevelopmentRegulatory affairsGCPClinical Data ManagementCROoncologyMedical writing

Skills and Expertise

Self Assessment :
Analytical skills Create SOPs Interact with physiciansAdverse event reportingAssess adverse reactionsAssess subject safety

Education

  • Diploma in clinical research in Clinical research and regulatory affairs from Manipal University in 2009
  • BDS in Dentistry from Rajiv Gandhi University of Health Sciences in 2004
  • BDS in Dentistry from Sri Siddhartha Dental College in 2004

Languages

BrightOwl Assessment:
Self Assessment:
KANNADA
Native
English
Full Proficiency
Hindi
Professional Proficiency

Work Preferences

  • Notice Period:
    9 weeks
  • Positions I am interested in:
    Clinical Safety Associate Drug Safety Officer Pharmacovigilance Officer Pharmacovigilance Assistant
  • Locations I am interested in:
    Bangalore, Karnataka, India Denmark
  • Work From Home:
    No
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Copenhagen, Denmark

Others

Driving License
  • No

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