Analista de Farmacovigilância Jr - São Paulo

Apenas para membros registrados São Paulo, Brasil

há 18 horas

About Galderma · Galderma is the leading company in the category dedicated to dermatology, present in approximately 90 countries. We provide an innovative, science-based portfolio of premium brands and services that cover the entire spectrum of the fast-growing dermatology market ...

Descrição do trabalho

About Galderma

Galderma is the leading company in the category dedicated to dermatology, present in approximately 90 countries.

We provide an innovative, science-based portfolio of premium brands and services that cover the entire spectrum of the fast-growing dermatology market, through Injectable Aesthetics, Dermocosmetics, and Therapeutic Dermatology.

Since our foundation in 1981, we have dedicated our focus and passion to the largest organ of the human body - the skin - meeting the individual needs of consumers and patients with superior outcomes in partnership with healthcare professionals.

We are advancing dermatology for every skin story, because we understand that the skin we are in shapes our life stories.

Working at Galderma

At Galderma, you will have the ultimate opportunity to gain transformative work experiences.

We are committed to meeting the individual needs of consumers and patients, with superior outcomes, in partnership with healthcare professionals.

In our company, we embrace differences and respect diversity, privacy, and the personal rights of every employee. We are committed to maintaining a respectful and inclusive workplace.

We take pride in our dedication to diversity and inclusion and want to ensure that the people we do business with know, share, and respect our standards.

If you are looking to put your ideas into practice, make a difference, and live out your purpose, your place is here.

Core mission
Ensure the PV System working as required by the company pharmacovigilance system, local PV, regional and international regulations.
Activities and responsibilities

Ensure quality management of all procedures, implementation of the audit findings and Pharmacovigilance improvement projects in Latin America, participating in the constant mapping of the implemented processes and review control of the documents, and direct line of communication with the responsible by Pharmacovigilance of Europe (EU-QPPV), aiming the continuity of compliance with Latin America regulations, local, regional and international legislations and global pharmacovigilance policies.

Ensure that any request from the Health Authorities regarding safety information necessary to assess risk-benefit for Galderma products, being available 24/7, in order to send complete answer and in accordance with regulatory deadlines in current legislation.

Operate the vigilance routine actions of Galderma Latin America post-marketing surveillance, through review and submit to Global Pharmacovigilance (Corporate) the adverse event reports, in order to ensure the compliance with national, regional, global, legal and contractual rules.

Implement, elaborate, review and approve the procedures related to Latin America Pharmacovigilance and keep them updated, through periodic search of pharmacovigilance regulations of Latin American and global procedures, aiming the notifications quality of adverse events with Galderma products in accordance with current legislation and related good practice guides.

Review and ensure the implementation of pharmacovigilance training post-marketing Surveillance to all employees of Galderma Brazil, Latin America LSOs and Regional PV Staff, through periodic Pharmacovigilance actions according to the presential and conference call/web meeting scheduled trainings, in order that all employees of Galderma America Latin be able to identify and report any adverse events related to Galderma products.

Collaborate, when applicable, with activities related to periodic Pharmacovigilance reports, Pharmacovigilance Plan and Risk Minimization Plan, when necessary, in order to ensure the monitoring of Galderma products safety profile.

Notify and review the spontaneous reports of drug adverse events to all Health Authorities in Latin America with Galderma Affiliate, through an electronic form on the regulatory agency website, in order to comply the current legislation.

Ensure that all files related to the Pharmacovigilance and Customer Service areas will be manage following Good Practice of Pharmacovigilance through periodic and continuous document reviews, in order to guarantee traceability according to the current legislation.

Participate in meetings with national entities, public authorities, organizations and associations of Pharmacovigilance and Customer Service, aiming alignment with market actions and anticipation of regulatory and legal needs.

Follow and support compliance metrics in Pharmacovigilance, through KPIs aiming the improvement of quality processes.

Support, as applicable, the execution of corporate audits at Galderma Affiliates in Latin America Countries and execute audits at Distributors under LATAM Regional responsibilities, aiming ensure the Good Pharmacovigilance Practices.

Knowledge and Skills:
Verbal and written communication skills
Relationship, problem-solving & negotiating skills.

Work Experience: 2-5 years

Conducting Pharmacovigilance/vigilance process

Education:
Bachelor's Degree in health professions or equivalent experience/qualification
Advanced in English
Desirable Spanish

BENEFITS:

Meal and Food Allowance
Mobility Allowance / Parking
Life Insurance
Medical Assistance
Dental Assistance
Childcare Assistance
Annual Bonus
Private Pension Plan
Pharmacy Agreement
Wellhub
Birthday Day Off
Paternity Leave - 30 days
Maternity Leave - 6 months
Discount Club
100% subsidized company products
Home Office
Short Friday

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