Pharmacovigilance Pharmacist
Resume:
Jacqueline S. Ang, RPh, PharmD
**** *** ******** *****, ******** St., Barangay Valencia, Quezon City adl77f@r.postjobfree.com
PROFESSIONAL PROFILE
A registered pharmacist with almost 3 years of experience of adverse drug events reporting. Seeking
to use my experience to acquire the position of Pharmacovigilance Officer where I get an opportunity to work under the able guidance of an expert and enhance my knowledge in Pharmacovigilance.
KEY SKILLS
Remarkable knowledge of scientific terms, medical terminology and medications
Current work with Argus safety database
Quality review of post marketing cases
Coding of event terms utilizing MedDRA
Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients.
PROFFESIONAL EXPERIENCES:
Safety Specialist, Jul 2019 – Current
Pharmaceutical Product Development, Philippines
Team leader for team’s day shift
Responsible for processing Serious Adverse Event (SAE) which includes review, safety
database entry, tracking, narrative writing, requesting follow-up from site and reporting to client (s) or agencies for assigned projects.
Responsible for adhering to PPD’s corporate policies, SOPs/WPDs, and awareness of ICH GCP guidelines and other relevant global and local regulations.
Effectively interface with Project Teams, Client Companies, and Investigators regarding SAE
activities.
Review and understands assigned study specific budgets.
General understanding of pathophysiology and the disease process, more detailed knowledge of relevant therapy areas as required for processing SAEs.
Ensure any expedited safety reports are notified to applicable Regulatory Authorities, Ethics Committees and Principal Investigators within regulatory timelines.
Provide project specific safety training to PPD Clinical on assigned projects
Responsible for coordinating and performing adverse event (SAE/AE) triage, data entry into PPD owned or client provided adverse event database, review of entered cases for quality, consistency and accuracy, follow up with reporter and/or associated HCP, tracking of reports, and reporting activities.
Code adverse event terms and write narratives according to client convention.
Assist with preparation and review of regulatory reports.
Review literature articles/abstracts and process adverse event reports from literature per program and regulatory requirements
Maintain knowledge and understanding of PPD and client-provided SOPs and current local and global regulations.
Effectively communicate with team members, client contacts and adverse event reporters
Associate Safety Specialist, Aug 2017 – Feb 2019
Pharmaceutical Product Development, Philippines
Works independently to receive, triage, manage, and reconcile adverse event reports, including those reported in the scientific literature, in accordance with contractual and regulatory timelines.
Manages adverse events and endpoints which may include review of complex medical records, preparation of adverse event narratives and coding of event terms utilizing MedDRA.
Assigns preliminary seriousness and labeledness/listedness of event(s). Works within multiple databases. May interact with clients, health care professionals, clinical trial personnel and consumers.
Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals.
Maintain medical understanding of applicable therapeutic area and disease states.
May participate in on-call duties for specific projects to ensure 24-hr coverage for safety reporting.
Reviews cases entered for quality, consistency and accuracy, including review of peer reports.
Junior Clinical Pharmacist, Oct 2014 – Aug 2017
Makati Medical Center, Philippines
Checks the appropriateness of the drug prescribed by the doctor with respect to the patient’s demographics, status, and medication history.
Identifies drug-drug interaction, therapeutic duplication and contraindication to other diseases of the patient.
Advises the doctor of any findings in relation to the inappropriateness of the drug and recommends resolution to identified drug-related problem.
Checks correctness and accuracy of doctor’s medication order as transcribed by the nurse.
Conducts medication reconciliation between the drug prescribed versus drug taken at home and drugs taken during confinement.
Provides medication counselling to patients about their drug therapy.
Verifies correct floor stock medication labelling and arrangement.
Monitor security and completeness of dangerous drugs.
Serves as on the job preceptor to undergraduate pharmacy student interns.
EDUCATION AND TRAINING:
Doctor of Pharmacy, Jun 2011 – Mar 2013
Centro Escolar University, Philippines
Bachelor of Science in Pharmacy, Jun 2007 – Mar 2011
Centro Escolar University, Philippines
Contact this candidate