Experience

Bluefish Pharmaceuticals

• Sweden
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Assistant Manager Pharmacovigilance

  • Jul 2021 - Present

  Bengaluru, Karnataka, India Review of - • Signal management reports • Risk Management Plan (RMP) and risk minimization (RMM) activities • Addendum to Clinical Overview (ACO) • Periodic Safety Update Report (PSUR) • PV intelligence report including EURD list • Pharmacovigilance System Master File (PSMF) • Documents/responses being submitted to the competent authorities • Safety communication documents • Random ICSRs and EVWEB cases • Business Continuity Plan (BCP) Responsible for -… Show more Review of - • Signal management reports • Risk Management Plan (RMP) and risk minimization (RMM) activities • Addendum to Clinical Overview (ACO) • Periodic Safety Update Report (PSUR) • PV intelligence report including EURD list • Pharmacovigilance System Master File (PSMF) • Documents/responses being submitted to the competent authorities • Safety communication documents • Random ICSRs and EVWEB cases • Business Continuity Plan (BCP) Responsible for - • Writing, reviewing, revising, approving, and training/implementation of relevant PV SOPs • EQMS management • Maintenance of pharmacovigilance (PV) quality management system (QMS) in accordance with EU and worldwide PV legislations • GAP analysis against the updated PV legislation • Record retention process • Maintenance of Standard Operation Procedures (SOPs) and policies • Process owner for PV training • Assisting Qualified Person Responsible for Pharmacovigilance in the EU (QPPV) for the quality activities • Reviewing the PV quality system at regular intervals in risk- based manner to verify its effectiveness and introducing corrective and preventive measures where necessary • Identifying and investigating concerns arising within the organization regarding suspected non-adherence to the requirements of the quality and PV systems and taking corrective, preventive and escalation action as necessary • Coordinating Annual audit program • Coordinating for Audit of external parties for ensuring pharmacovigilance compliance • Monitoring of deviation and CAPA status • Monitoring and review of audit and inspection findings and CAPA response • Collating and finalizing annual quality plan • Ensuring that contractual obligations defined in PV agreements are followed • Ensuring compliance with the legal requirements for PV tasks and responsibilities • Actively working with QPPV to implement and embed robust PV processes with appropriate KPI to drive performance for QMT • BCP testing and coordination Show less



Syneos Health

• United States
• Biotechnology Research
• 700 & Above Employee

• Senior Safety Specialist

  • Apr 2015 - Jul 2021

  Gurgaon, India • Training and mentorship. • Quality review for cases. • Query resolution for team. • Case Processing for safety reports. • Medical coding with MedDRA and WHO-DDE. • Preparation of QC track sheets, performing quality analysis over various parameters. • Managing various Pharmacovigilance Safety tools.



APCER Life Sciences

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Pharmacovigilance (Drug Safety) Associate

  • Jun 2014 - Apr 2015

  Delhi • Case Processing for ICSRs, Literature reports and Clinical Trial reports. • Medical coding with MedDRA and WHO-DDE. • SAE reconciliation, UAT (User Acceptance Testing), scripts validation and DATA Migration. • Preparation of QC track sheets, performing quality analysis over various parameters. • Triaging of incoming reports for completeness, validity and perform the primary evaluation of seriousness, expectedness and causality of the reports • Book In the data in… Show more • Case Processing for ICSRs, Literature reports and Clinical Trial reports. • Medical coding with MedDRA and WHO-DDE. • SAE reconciliation, UAT (User Acceptance Testing), scripts validation and DATA Migration. • Preparation of QC track sheets, performing quality analysis over various parameters. • Triaging of incoming reports for completeness, validity and perform the primary evaluation of seriousness, expectedness and causality of the reports • Book In the data in IRMS database, determination of Initial and follow up cases, writing complete Narrative with specific details to have summary of the case along with experience in ARGUS and ARISg. • Managing varied Pharmacovigilance Safety tools like PHOENIX, IRMS, PFIDO, PFITRACK and CITRIX. Show less



Wipro

• India
• IT Services and IT Consulting
• 700 & Above Employee

• Pharmacovigilance Officer

  • Aug 2013 - Jun 2014

  Preperation of Adverse Event Monitoring Form to be submitted to USFDA and providing information to Leading Doctors and other Healthcare professionals about various drugs, side effects etc...



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sales officer

  • Jul 2010 - Jun 2011

  Sales and marketing