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Summary

Experienced Pharmacovigilance professional with a demonstrated history of working in the pharmaceuticals industry. Skilled in Good Clinical Practice (GCP), Pharmacovigilance, Regulatory Requirements, Drug Development, and Pharmaceutical Industry. Strong information technology professional with a PGDPHV focused in Pharmacovigilance from ICRI.

Experiences

Current Experience

  • Pharmacovigilance Manager
    Since April 2017
    Manage daily workload in conjunction with Associate Vice President for individual case processing, literature searches, PSUR generation and any other tasks relevant to the Pharmacovigilance Department. • Management of Compliance with the Company Standard Operating Procedures and regulatory requirements. • Liaise effectively and maintain excellent relationship with the clients and internal/external contacts • Maintain awareness of changes to/new regulations affecting pharmacovigilance activities. Communicate new or changed regulations to management and to relevant members of the department in order to initiate any change in processes. • Builds and maintains good relationships across functional units and company affiliates. • To carry out necessary administrative duties required for the job. • To contact, as required the UK/US office(s) and customers/clients in order to achieve required outcomes and meet timelines. • Other duties as assigned by management.

Past Experience

  • Deputy Manager
    April 2016 --- March 2017
    Manage daily workload in conjunction with General Manager Pharmacovigilance for individual case processing, literature searches, PSUR generation and any other tasks relevant to the Pharmacovigilance Department. • Management of Compliance with the Company Standard Operating Procedures and regulatory requirements. • Liaise effectively and maintain excellent relationship with the clients and internal/external contacts • Maintain awareness of changes to/new regulations affecting pharmacovigilance activities. Communicate new or changed regulations to management and to relevant members of the department in order to initiate any change in processes. • Builds and maintains good relationships across functional units and company affiliates. • To carry out necessary administrative duties required for the job. • To contact, as required the UK/US office(s) and customers/clients in order to achieve required outcomes and meet timelines. • Other duties as assigned by management.

  • Assistant Manager - Pharmacovigilance
    April 2015 --- April 2016

  • Team Lead-Pharmacovigilance
    December 2012 --- March 2015
    • Manage daily workload in conjunction with Senior Pharmacovigilance Manager for individual case processing, literature searches, PSUR generation and any other tasks relevant to the Pharmacovigilance Department. • Data Entry and Quality Check of ICSRs in APCER’s pharmacovigilance database (ARISg) and other case management activities. • Management of Compliance with the Company Standard Operating Procedures and regulatory requirements. • Liaise effectively and maintain excellent relationship with the clients and internal/external contacts • Maintain awareness of changes to/new regulations affecting pharmacovigilance activities. Communicate new or changed regulations to management and to relevant members of the department in order to initiate any change in processes. • Builds and maintains good relationships across functional units and company affiliates. • To carry out necessary administrative duties required for the job. • To contact, as required the UK/US office(s) and customers/clients in order to achieve required outcomes and meet timelines. • Other duties as assigned by management.

  • Senior Pharmacovigilance Associate
    October 2010 --- December 2012
    • Manage daily workload in conjunction with Team Lead for individual case processing, literature searches, PSUR generation and any other tasks relevant to the Pharmacovigilance Department. • Data Entry and Quality Check of ICSRs in APCER’s pharmacovigilance database (ARISg) and other case management activities. • Management of Compliance with the Company Standard Operating Procedures and regulatory requirements. • Builds and maintains good relationships across functional units and company affiliates. • To carry out necessary administrative duties required for the job. • To contact, as required the UK/US office(s) and customers/clients in order to achieve required outcomes and meet timelines. • Other duties as assigned by management

  • Pharmacivigilance Associate
    March 2010 --- September 2010
    • Manage daily workload in conjunction with Senior Pharmacovigilance Associate for individual case processing, literature searches, PSUR generation and any other tasks relevant to the Pharmacovigilance Department. • Data Entry and Quality check of ICSRs in APCER’s pharmacovigilance database (ARISg) and other case management activities. • Builds and maintains good relationships across functional units and company affiliates. • Other duties as assigned by management

  • Pharmacovigilance Executive
    February 2009 --- February 2010
    • Manage daily workload in conjunction with Senior Pharmacovigilance Associate for individual case processing, literature searches, PSUR generation and any other tasks relevant to the Pharmacovigilance Department. • Data Entry of ICSRs in APCER’s pharmacovigilance database (ARISg) and other case management activities. • Builds and maintains good relationships across functional units and company affiliates. • Other duties as assigned by management.

  • Observer
    January 2008 --- October 2008

Knowledge

LinkedIn Assessment :
ARISgDrug SafetyDrug DevelopmentRegulatory affairsClinical researchPharmacovigilancePharmaceutical IndustrySOPMedical writingRegulatory RequirementsClinical DevelopmentICH-GCPCROClinical trialsGCPARGUS

Education

  • PGDPHV in Pharmacovigilance from ICRI in 2009
  • BDS in Dentistry from DJ College of Dental Sciences in 0
  • PHDHA in Hospital Administration from YMCA in 0

Area / Region

Delhi, India

Others

Driving License
  • No