...reports submissions Authorities
Abide by the Quality Management System standards and requirements of CGSDCI
Attend internal, pharmacovigilance, and project-specific training
Abide by the Quality Management System standards and requirements of the CGSDCI
Ensure...
...now and in the future.
Discover Impactful Work:
Provides administrative safety support to the safety reporting team and Pharmacovigilance department.
Responsible for tasks related to receipt and submission of expedited and periodic safety reports, including...
Remote job
...treatment decisions (comparable to 2 years); Or.
Direct experience in medical review and assessment of safety information/Pharmacovigilance (comparable to 3 years).
Physical Requirements / Work Environment
Requirements
Thermo Fisher Scientific values the health...
...and
licenses as necessary for renewals and submit the necessary requirements ahead of
time.
. Act as the authorized pharmacovigilance officer for the company by actively coordinating
the issues of product complaints/quality with the end-user and or regulatory...
...JOB DESCRIPTION
Project: Pharmacovigilance account
Role: Drug Safety Associate
Preferred Educational Qualification for the role: Registered Nurse / Registered Pharmacist / Any Life Sciences Courses Graduate
Preferred experience for the role: A minimum of 1...
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...
...Role: Pharmacovigilance Associate Office based with flexibility: 24th Floor, Tower B The Salcedo Tower, 169 H.V Dela Costa Street, 1227 Makati City, Philippines
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule...
...Review medical safety signals and ensure proper disposition and Review data from the company post-marketing database and related pharmacovigilance sources, as needed.
Provide support in the preparation and conduct of cross-functional meetings which involve the medical...
...associations, and working groups discussions to ensure positive outcomes for the company.
Act as Qualified Person responsible for Pharmacovigilance
Essential Duties and Responsibilities:
Initiate and develop complex regulatory project plan
Monitor applicable...
...The successful candidate will have 2+ years of relevant clinical research/pharmaceutical industry experience, preferably in pharmacovigilance/drug safety, with knowledge of medical terminology and coding systems.
Experience with Argus is highly preferrable
Must...
...Performs literature search and prepares timely reports (i.e., literature review report) on company products
Member of the Pharmacovigilance Risk Assessment Committee
Develops, implements, and maintains the team's Procedural Documents
Required Qualifications:...
...Ability to make basic decisions with an understanding of the consequences.
Technical Skill Requirements
Experience in pharmacovigilance, in clinical care, or in clinical or scientific research is an advantage but not a requirement.
Demonstrated computer literacy...
...the actual product in the actual product realization and service provision to guarantee product quality.
Acts as deputy LVO (Pharmacovigilance Officer)
Required Qualification / Experience
University degree in Chemistry and or Pharmacy
Licensed Chemist or...
.... The role will also liaise with Sales, Marketing, MAPA, HR & Admin, Finance, Quality, CMRPV (Continuous Process Verification Pharmacovigilance), CE (Commercial Excellence), as well as key external stakeholders such as hospitals, industrial, sub-distributor and government...
...and implementation of product surveillance of spontaneous adverse event reports, product specific medical safety assessments, pharmacovigilance, and risk mitigation plans.
Assist in the evaluation of novel and computer assisted tools and methodologies for analysis...
...are implemented in case contractual commitments are not met, as applicable.
Drive the local impact assessment of new local pharmacovigilance-related legislation and provide support to Global PS organization on local PV matters and local change impact. Ensure the local...
...and Supervisor.
The Local Vigilance Officer (LVO/LSO) Officer Deputy is responsible for establishing and maintaining a local pharmacovigilance (PV) system and procedures within the country.
15th April, 2024
What is your role?
The QA Specialist is...
...conduct, and company policies and procedures
Administrative - Comply with administrative reports and other requirements
Pharmacovigilance - Report "adverse events"
Resource Utilization - Exhibit proper care and maintenance of company properties and resources...
...required, with Advanced knowledge of pertinent local regulations.
Attendance to PhFDA Academy trainings on: QPIRA, Licensing and Pharmacovigilance.
Knowledge of diabetes, as well as of other therapeutic areas and/or biotech products relevant to Novo Nordisk are...
...Quality Management System
Qualifications:
. Graduate of Bachelor of Science in Pharmacy
. With specific knowledge of Pharmacovigilance process and activities
. Experience in working alone and in close-knit teams, either in a medical or pharmaceutical...
...CAPAs and Change Requests
Training of colleagues globally in relation to responsibilities
Dedicated responsibilities
Pharmacovigilance; agreements, training, compliance
Corporate responsible for registration strategy in collaboration with the commercial departments...