Global Order Entry Manager/Operations Manager

• Jun 2019 - Present

Pharmacovigilance Associate III

• Jun 2017 - Mar 2019

Sr. Medical Writer

• May 2015 - Jun 2017

• Responsible for authoring and submission of various aggregate reports (PBRER/ PSUR). • Coordinated and conducted all start to end activities during report preparation. Evaluate and address comments received from stakeholder reviews on reports • Performed literature search for ICSRs, aggregate reports and signal management activities • Performed quality check and review for all aggregate reports • Responsible for generation and review of line listings for PBRER/PSUR • Responsible for preparation and revising the working instructions, Standard Operating Procedures • Developed and implemented Aggregate Reports Templates for Pharmacovigilance reports • Involved in Data Base Migration (Argus) and OQ/PQ activities • Performed monthly reconciliation of reports issued and sharing the data with the client • Working knowledge of writing sections of PBRER, case annotations, medical assessments, evaluation of risks and signals; generation and review of Line Listings etc. • Maintaining, reviewing and performing reconciliation of compliance metrics tracker • Conducted CT reconciliation, collecting source documents, conducting Strategy Meetings and Planning Meetings with the stakeholders • Authoring PBRERs, performing peer review, reviewing Line Listings, scrutinizing source documents, seeking clarification with the stakeholders on shared inputs, addressing stakeholder comments and submitting reports to company regulatory • Conducted trainings and mentoring for new joiners Show less

Team Leader/ PSUR Writer/ SME- Pharmacovigilance/ Novartis Certified Trainer/ Drug Safety Associate

• Apr 2010 - Apr 2015

Cognizant Technology Solutions (10 Apr 2010 to 30 Apr 2015) Team Leader/ PSUR Writer and Novartis Certified Trainer – Mumbai, India (Jul 2014 to Apr 2015). Worked as Team Leader, PSUR Writer and Novartis Certified Trainer for Novartis Project in CTS, Mumbai. • Authored multiple PSURs and ARs for Novartis Products. • Activities performed such as conducting planning meetings, sales data calculations, writing sections in reports, reviewing reports, generating line listings and submitting reports. Team Leader Pharmacovigilance/Novartis Certified Trainer/ Pharmacovigilance SME-India and Argentina (Jun 2011 to Jul 2014) • Performed all team lead activities and managed different teams with 15 to 25 associates. • Performed activities such as reconciliation of cases on daily, monthly and yearly basis. • Performed associate appraisals and ratings. • Took many candidates interviews in PV hiring. Worked in PV associate hiring programmes. Also conducted many huddles and sessions in order to accelerate productivity, quality and work efficiency. • Attended fortnightly client calls on project updates. • Experienced on creation of Action Items in Argus safety database and sampling. • Worked in seeking follow-ups from all Country Pharma Organizations. • Experienced in ICSR QC and analysis. Worked on preparing RCA’s and CAPA’s. • Trained in working with MedDRA dictionary, WHO dictionary and Argus Safety database. • As a Novartis Certified Trainer, performed trainings and related activities for newly hired associates. Safety Processing Expert Novartis Hyderabad and Mumbai (Apr 2010 to Jun 2011) • Performed activities such as book-in, processing and reviewing of case reports. Initiation of follow-ups and clarifications on case quries. • Experienced in case processing in all therapeutic areas especially in Oncology. • Worked on Literatures and abstracts reviewing and screening. Show less

Clinical Research Associate

• Nov 2008 - Apr 2010

Worked as Clinical Research Associate in BBRC, Mumbai, for 18 months. Reviewing of bioavailability and bioequivalence protocols and handled multiple BABE projects. Prepared Case Report Forms (CRF’s) and Study Master File (SMF) according to protocols. Worked on registration and identification of human volunteers by using Smart Identification Biometric software. Experienced in dosing investigational product /products to human volunteers. Experienced in monitoring ongoing activities such as physical, ECG, vitals, pathological results, dosing, blood collection and centrifugation of blood samples. Prepared and scrutinized all documents regarding study. Prepared various SOP’s Show less