Архив: Регистратор (международная фармацевтическая компания). Киев.

Описание

The position of the Senior Associate regulatory affairs and safety, CPPV back-up should be opened in connection with the optimization of structure of RA&QA Department in Ukraine. The position will cover both regulatory affairs and pharmacovigilance/vigilance activities as CPPV back up. CPPV back up should be mandatory included in the department staff under legislation requirements to guaranty  uninterrupted pharmacovigalance for medicines in Ukraine. 

 

MAIN DUTIES AND RESPONSIBILITIES 

. Adheres to the plan of registration (renewal) of medicines, medical devices, dietary supplements, cosmetics, etc.

-  Maintains by the contracts with the authorities bodies and expertize organizations for the evaluation and registration of medicines, conformity assessment of medical devices, safety examination of dietary supplements, cosmetics, etc., as well as other authority bodies for the provision of services for product registration.

-  Completes dossier for submission to the State Administration of Medicinal Products of Ukraine and drug control with the purpose of obtaining a conclusion on confirmation of the production of medicines with the requirements of good manufacturing practice (GMP).

- Performs all needed operations to order, receive and submit to authority the samples and other materials and facilities and necessary supporting documents for the examination a medicinal product, a medical device, and etc. which is submitted for state registration (renewal), or other procedure established by law.

-  Provides notarization, translation from foreign languages ??and legalization of registration documents for submission to state registration bodies.

-  Plays orders and receives product samples and chemical reagents for laboratory examination.

-  Completes materials of registration dossiers for obtaining of sanitary-epidemiological expertise conclusions for cosmetics and biocides.

-  Conducts correspondence on the examination of registration materials and ensure proper accounting of originals and copies of letters.

-  Performs continuous monitoring of preparation, acquisition and submission to the examination bodies and state registration of registration dossiers.

-  Performs all needed activities during the absence of an authorized (contact) pharmacovigilance person to guaranty the pharmacovigilance system in Ukraine functions properly.

-  Ensures that all procedural processes regarding pharmacovigilance are documented.

-  Receives, registers, reports and stores information on adverse drug reactions in Ukraine.

- . Ensures submission of all related documents, in accordance with regulatory requirements and good pharmacovigilance practices, to the Ministry of Health and the Authorized Body of Ukraine;

-  Submits safety reports to the Authorized Body in a timely manner.

-  Timely submits to the Authorized Body changes regarding the system of pharmacovigilance, changes in the labeling of medicinal products;

-  Checks reports on monitoring information in medical publications or properly cooperate with consulting organization for literature search.

-  Control the validity of Pharmacovigilance Contracts and controls the requirement to exchange by pharmacovigilance information in contracts with 3d organizations.

-  Conducts training with the staff of the company that works with medicines; conducts trainings for employees of 3d organizations working with the company's medicines.

-  At the request of the Pharmacovigilance Authority, it shall provide additional information necessary to evaluate the benefit / risk balance of the medicinal product, including the sales volume of the medicinal product, information on post-registration studies on the safety and efficacy of the medicinal product.

-  Ensures timely reporting of adverse reactions for medicines

-  Ensures proper archiving and storage of registration and pharmacovigilance documentation.

-  Within the corporate pharmacovigilance system, performs the tasks of a local pharmacovigilance contact for medicinal products and medical devices in accordance with the requirements of approved standard operating procedures.

-  Notifies the Authorized Body, takes the necessary steps and arranges for changes and additions to the safety information of the medicinal product, reflected in the instructions for medical use / summary of the medicinal product, in case of detection of previously unknown dangerous properties of the medicinal product that have caused or could cause us severe human health and life, or changes in the benefit / risk ratio of risk.

 

 












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Город

Киев

Категория

Медицина и фармацевтика