Deepanshu Kumar Chitra

About Deepanshu Kumar Chitra

Experienced in pharmacovigilance activities (both human and veterinary), ICSR Triage and Processing including E2B reports along with Quality Review and Submission of Reports. Hands on experience on Argus Safety and PV entry since Jun 2018. Types of reports handling include spontaneous, non-interventional trials, managed access programs, social media reports, patient oriented programs. Experienced in Prescription Auditing, Clinical Ward Rounds; Possess In-depth Knowledge of Pharmacovigilance field; Certified by American Heart Association in providing ACLS and BLS, by WHO-UMC in Signal Detection and Causality Assessment; Strength at finding medication errors and drug related problems

Experience

1. Senior Associate Manager-det-dpm

   Elanco

   Apr 2023 — Present · Bangalore Urban, IN

   Hands on Drug Safety Database Experience:PV-EntryAdverse Event and Product Complaint Data Entry:Data entry and causality assessment of AE/PC reports in the PV database.Completeness and accuracy of data collection, data entry and case assessment activities including medical coding (VeDDRA), narrative writing, causality assessment, reportabilities, seriousness assessment with reason for assessment for causality selection.MAH notifications.Regulatory, quality knowledge and compliance requirements associated with execution of the role.Internal and external timelines compliance.Case processing issues identification with potential for delay in submission and escalation to management.Case allocation and prioritization.Mentoring of new team members.Process improvement and innovation drive and support.Global GPV Support:Keep current on global regulatory issues and practices related to GPV.Assist with support of internal partners in GPV related activities as necessary.Partner and communication with GPV colleagues.Management of global adverse events mailbox.Support on PMRA incident forms for Canada.Training:Training new joiners for case processing along with certification and review.Providing ad-hoc trainings while in live.Miscellaneous:Quality huddles.Tracking cases, allocation master tasks, identifying reasons for delayed cases.Communicating relevant process updates to the team.Deviation and CAPA handling.Collaboration/Support Internal and External Customers:Communicate effectively with Elanco business partners.Assistance with reimbursement and product complaint requests.Review of contacts classified as inquiries to ensure lack of embedded adverse event or product complaint reports.Identify opportunities for increased efficiencies and collaborate with business partners to implement solutions.

Education

• ISF College Of Pharmacy

  Doctor of Pharmacy (Pharm.D.), Pharmacy Practice

  2012 — 2018