Team Lead Resume Example Peoples Health Centers Family Of Companies

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 2014Peoples Health Centers Family Of Companies

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 2014Amag Pharmaceuticals, Inc.

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 2013Frame

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 2008Medi Marketing, Inc － Saint Louis

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 － City, State, USA

Bachelor of Science : Pharmacy, 2006University of Santo Tomas － City, 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

Resume Overview

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

Team Lead Resume Example

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