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Team Lead Resume Example

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TEAM LEAD
Professional Summary

Graduate of Bachelor of Science in Pharmacy with major professional experience in Pharmacovigilance/Drug Safety (Case Processing through Global Regulatory Submissions)

Licenses

Philippine Pharmacy Licensure Examination (2006)

Skill Highlights
  • Pharmacovigilance
  • Drug Safety
  • Pharmaceutical Industry
  • Medical Writing
  • Regulatory Submissions (FDA, EMEA, MHRA, Other Local Health Authorities)
  • Adverse Event Reporting
  • MedDRA Coding
  • GCP
  • Regulatory Affairs
  • CRO
Professional Experience
Team Lead
May 2014 to December 2014
Sciformix (for Johnson and Johnson Consumer)
  • Managed a team of 8 members (4 for Case Processing and 4 for Regulatory Submissions)
  • Lead pharmacovigilance activities (tracking of safety data reports from initial receipt, triage, entry, expedited and non-expetied reporting/submissions; business partner reconciliations; to closure)
  • Performed in-depth quality review of all safety data reports to promote data consistency and to evaluate performance of the team
  • Acted as point-of-contact for feedbacks to regulatory authorities and/or business partners to address queries and/or resolve issues
  • Involved with the core team in implementing continuous review and amendment of standard operating procedures, work instructions, and pharmacovigilance conventions
  • Involved with the core team in monthly and annual review and discussions of metrics to ensure delivery of timely and quality services according to client service level agreements
  • Actively participated in various internal and external audits (US FDA in Sep 2014; Pfizer in Sep 2014)
  • Databases utilized: IRT, SCEPTRE, LCRx, ARGUS
Senior Safety Data Analyst
May 2013 to May 2014
Sciformix (for Johnson and Johnson Consumer)
  • Primarily performed expedited and non-expedited reporting/submissions to the regulatory authorities (US FDA, EMEA, MHRA, other local health authorities) and/or business partners within the specified regulatory reporting timelines and according to specified Pharmacovigilance conventions of the regulations
  • Performed in-depth quality review of cases entered in IRT and SCEPTRE intended for submission to regulatory authorities and/or business partners
  • Liaised with business partners and/or affiliates to address queries and/or resolve issues concerning cases
  • Performed any other support activities as assigned ­(tracking various types of information and metrics, ongoing quality control of defined process steps, training of new hires, reconciliation of data from multiple sources)
  • Involved in the preparation of training materials and training per se for transition of entire team to Argus
  • Databases Utilized: IRT, SCEPTRE, LCRx, ARGUS
Drug Safety Analyst
April 2010 to April 2013
Hospira
  • Responsible for managing a literature event related to any generic product of Hospira through its entire life-cycle, from initial literature assessment, investigation, through regulatory reporting, and ultimately to closure/reopening as needed
  • Responsible for knowing when an event is sufficiently complex with significant consequences to escalate the event
  • Responsible for creating safety reports using drug safety databases (ARISg, CLINTRACE and TRACKWISE)
  • Performed analysis in order to determine the general cause of issues utilizing information obtained in the course of assessment, investigation, and communications, appropriate for situations with potential regulatory risk
  • Performed quality review for cases of team members before final submission to regulatory authorities
  • Assisted team members in facilitating a single literature event throughout its entire life cycle
  • Ensured consistency across responsible product/group/family system
  • Provided training, assistance, mentoring and guidance to new hires and team members
  • Performed any other support activities as assigned ­ preparation of core labels for company products as references for the entire Hospira safety unit
  • Databases utilized: TrackWise, ARISg, Clintrace
Assistant Editor
March 2007 to November 2008
Medi Marketing, Inc - Makati, Philippines
  • Handled an entire publication, with assistance of 5-8 contractual staff members, from initial stages of editing/encoding, reviewing/updating, proofreading/revising of drug literature according to the company's editorial guidelines and format (MIMS Hong Kong ­ quarterly; MIMS Annual Hong Kong)
  • Liaised with global clients and affiliates to produce quality and timely publications
Education and Training
2013Train the Trainer Argus System - Horsham, PA, USA
Bachelor of Science : Pharmacy, 2006University of Santo Tomas - Manila, Philippines
Interests
Singing Hosting Events/Public Speaking Educational/Leisure Traveling Photography
Personal Information
Ability to Work under Pressure Willingness to Work Overtime Willingness to Relocate God-fearing, Responsible, Efficient, and Delivers Quality Output
Additional Information
  • Ability to Work under Pressure Willingness to Work Overtime Willingness to Relocate God-fearing, Responsible, Efficient, and Delivers Quality Output OTHER PERSONAL SKILLS & INTERESTS Singing Hosting Events/Public Speaking Educational/Leisure Traveling Photography
Skills
Chemistry, Interpersonal, Computer Literacy, Clients, customer service, Databases, delivery, editorial, editing, Fluent English, English, Information Systems, MAC, managing, mentoring, Windows operating systems, MIMS, Pharmacology, processes, proofreading, publications, publication, quality, reporting, safety, Service Level Agreements, Trainer, training materials
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Resume Overview

Companies Worked For:

  • Sciformix (for Johnson and Johnson Consumer)
  • Hospira
  • Medi Marketing, Inc

School Attended

  • Train the Trainer Argus System
  • University of Santo Tomas

Job Titles Held:

  • Team Lead
  • Senior Safety Data Analyst
  • Drug Safety Analyst
  • Assistant Editor

Degrees

  • 2013
    Bachelor of Science : Pharmacy , 2006

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