ROANNE M. PEGARRO, RPh

Address: #*** ******* ******** **. ******** Calatagan Batangas

Contact Numbers: +639********* / +639*********

E-mail Address: adm09n@r.postjobfree.com

Expected Salary: Negotiable

OBJECTIVE: I am willing to give total support to the organization that I am in, with the experience and capability that I have, in order to achieve organization's goals and create mutual benefits.

WORK EXPERIENCE

CELLTRION GLOBAL SAFETY DATA CENTER, INC. (CGSDCI) SR. REGULATORY SUBMISSIONS ASSOCIATE

February 2020 – Present

- Performs case assignments to the team

- Performs gap-analysis, elaborations and maintenance of company Standard Operating Procedures (SOPs) and Work Instructions (WIs);

- Reviews technical agreements – Safety Data Exchange Agreement

- Ensures proper coordination with core team, partners and database service providers;

- Ensures maintenance and update of safety regulatory submissions tracker;

- Performs case reconciliation with partners and affiliates;

- Collects and reviews metrics for measuring reporting compliance; REGULATORY SUBMISSIONS ASSOCIATE

October 2018 – February 2020

- Ensures timely submission of reports (i.e. expedited reports, PSUR, PBRER) to worldwide regulatory agencies and partners in accordance with applicable regulations;

PHARMACEUTICAL PRODUCT DEVELOPMENT (PPD), INC

SR. SAFETY ADMINISTRATOR

Apr 2018 – October 2018

Duties and Responsibilities:

- Performs case assignments to the team

- Monitors inbox and answers queries from partners and PPD colleagues SAFETY ADMINISTRATOR (SUPPORT)

May 2016 – Mar 2018

Duties and Responsibilities:

- Provides contracted project coordination and safety support on global and domestic programs with an emphasis on serious and non-serious adverse events

- In collaboration with Safety Specialists and Medical Monitors, liaises and establishes effective relationships with internal functional team members to implement project and accurately manage all incoming safety documentation.

- Provides primary safety support to Pharmacovigilance staff including receipt of information, copying, filing, typing and distribution of letters, memos, reports, sending faxes and mailings, etc.

- Completes initial data entry of adverse events in the safety tracking system and/or safety database

- Logs information into tracking systems. Uploads documents received within the designated document repository

- Distributes project reports to the client and project team. Assists in the collation of study metrics for the team and archival of project documentation at closeout

- Assists in the set-up and management of program information through an administrative filing system so that information is readily available and accessible

- Assists with audit readiness

- Assists in training new safety support staff in department administrative and program- related tasks

- Identifies and redacts subject identifiers per local requirements, retrains sites and escalates reoccurrences to PPD Data Privacy

- Performs other duties as assigned

- Performs case reconciliation with partners and affiliates on a weekly basis Duties and Responsibilities:

- checks prescriptions to ensure that there are no errors and that they are appropriate and safe for the individual patient;

- provides advice on the dosage of medicines and the most appropriate form of medication, for example, tablet, injection, ointment or inhaler;

- discuss treatments with patients' relatives, community pharmacists and GPs;

- ensures medicines are stored appropriately and securely;

- answers questions about medicines from within the hospital, other hospitals and the general public;

- provides information on expenditure on drugs;

- prepares and quality-checking sterile medications, for example, intravenous medications;

- assists the chief pharmacist and other staff pharmacist on preparing the medication needed for clinical trials

EDUCATION

Tertiary:

Adamson University

Ermita Manila, Philippines (2006-2010)

Degree Earned: Bachelor of Science in Pharmacy

Date passed: June 2010 (GWA: 85.22 %)

PRC License: Licensed Pharmacist

License No. 0058507

SUMMARY OF QUALIFICATIONS

Able to operate Pharmacovigilance and Clinical Safety System like IRT, ARISg and ARGUS Computer Literate (MS-Word, MS-Excel, Power Point) Able to converse and write well in English

Highly motivated

Can work under pressure

PERSONAL INFORMATION

Date of Birth : November 05, 1989

Age : 29

Place of Birth : Pasig City, Metro Manila

Height : 4'7"

Civil Status : Single

Nationality : Filipino

Gender : Female

Weight : 50 kg

PERSONAL REFERENCES

REGINE GAYLE SIDOCON

CELLTRION GLOBAL SAFETY DATA CENTER, INC. (CGSDCI) Senior Regulatory Submissions Associate, PVG

Phone +63-935-***-****

STACY HUTCHERSON

PHARMACEUTICAL PRODUCT DEVELOPMENT (PPD)

Safety Admin Manager, PVG

Phone +1-919-***-****

Contact this candidate