Empregos
>
São Paulo

    Pharmacovigilance Coordinator - São Paulo, Brasil - Galderma

    Galderma
    Default job background
    Descrição

    With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries.

    We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology.

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

    Because we understand that the skin we're in shapes our lives, we are advancing dermatology for every skin story.
    We look for people who focus on getting results, embrace learning and bring a positive energy.
    They must combine initiative with a sense of teamwork and collaboration.

    Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day.

    We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future.

    Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

    At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world.

    With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.


    Location :
    CDMX, Mexico

    Objective :

    Act as LSO in the country where they are located i.e., management of safety information from various sources, including Healthcare professionals, literature, health authorities and interactions with Regional Head of PV and Global PV teams.

    Support submission of PV cases and periodic reports to health authorities (e.g., MX Cofepris).Act as the focal point for Local Safety Officers (LSOs) in Latin American Spanish countries (Argentina, Chile, Colombia, and Mexico) coordinating PV activities in the region and supporting business initiatives and distributors in the Spanish speaking Latam countries.

    Ensure compliance to local regulations and coordinate with other functions cross-functional activities.


    Responsabilities :

    • 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

    Profile :

    Academic Background:
    Professional education health with experience in Pharmacovigilance.
    Intermediate - Advanced English Work Experience: Between 3 and 5 years in Pharmacovigilance Experience in Pharmacovigilance, Technovigilance (device) and cosmetovigilance legislation in Latin America

    Employer's Rights:
    This job description does not list all the duties of the job.
    You may be asked by your supervisors or managers to perform other duties.
    You will be evaluated in part based on your performance of the tasks listed in this job description.
    The employer has the right to revise this job description at any time.

    This job description is not a contract for employment, and either you or the employer may terminate employment at any time, for any reason.

    In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.



  • Galderma São Paulo, Brasil Tempo integral

    With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans th ...


  • Elanco São Paulo, Brasil Tempo integral

    At Elanco (NYSE: ELAN) – it all starts with animals · As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We're driven by our vision of 'Food and Companionship Enriching Li ...


  • Knight Therapeutics Brasil São Paulo, Brasil

    The coordinator leads the bioequivalence and related projects for Knight products. Depending on the products and the requirements, the projects can include but not limited to pharmacological equivalence, comparative bioavailability, comparative bioequivalence, bioexemption, and c ...


  • Colgate-Palmolive São Paulo, Brasil

    Job Summary · The Consumer Affairs Jr Manager facilitates the consumer experience for all Colgate-Palmolive brands across traditional and digital channels, and is responsible for ensuring that all consumer and contact-center facing information is accurate, timely and comprehensiv ...


  • Msd Malaysia São Paulo, Brasil

    Responsibilities include, but are not limited to: The role is accountable for performance and compliance for assigned protocols and sites in a country; · Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, ou ...


  • Kenvue Sao Paulo, Brasil

    **Pharmacovigilance PL Specialist (fixed-term 24 months) | São Paulo** W · Description · Kenvue is currently recruiting for **Pharmacovigilance Specialist (fixed-term position)**. This position reports into the Americas Regional Head of the Local Safety Organization and is based ...


  • Thermo Fisher Scientific Sao Paulo, Brasil

    **Work Schedule** · Standard (Mon-Fri) · **Environmental Conditions** · Office · Summarized Purpose: · Performs day-to-day Pharmacovigilance (PV) activities performed within a highly regulated environment · and driven by strict timelines. Pharmacovigilance activities include but ...


  • Lilly Sao Paulo, Brasil

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve th ...


  • Amgen Sao Paulo, Brasil

    Career Category · Safety · **Job Description**: · Sr Associate Global Safety · Amgen local pharmacovigilance team is responsible for maintaining compliance for the activities under its responsibility. To this end, there is interaction with local teams in the medical, regulatory, ...


  • Amgen Sao Paulo, Brasil

    **Sr Associate Global Safety** · Amgen local pharmacovigilance team is responsible for maintaining compliance for the activities under its responsibility. To this end, there is interaction with local teams in the medical, regulatory, commercial and global areas, in addition to se ...


  • MSD Sao Paulo, Brasil

    Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medi ...


  • AstraZeneca Sao Paulo, Brasil

    A AstraZeneca é uma das empresas biofarmacêuticas mais fascinantes do mundo. Dos pesquisadores à equipe de vendas, dos técnicos de laboratório ao departamento jurídico, todos temos a missão de transformar ideias em ciência, ciência em medicamentos revolucionários que salvem e pro ...


  • Colgate-Palmolive São Paulo, Brasil

    Job SummaryThe Consumer Affairs Jr Manager facilitates the consumer experience for all Colgate-Palmolive brands across traditional and digital channels, and is responsible for ensuring that all consumer and contact-center facing information is accurate, timely and comprehensive t ...

  • Axios International

    Program Liaison

    há 4 semanas


    Axios International Sao Paulo, Brasil

    **Position Purpose** · The **Program Liaison (PL) **will assist the team in managing drug access program(s) in the region. The job holder is required to help represent Axios in daily meetings with patients, and doctors and carry out administrative duties which will be both field ...


  • Novo Nordisk Sao Paulo, Brasil

    Regulatory Affairs Analyst (Clinical Trials) · **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:São Paulo, São Paulo, BR- · **The Position**- Your responsabilities includes: · - Develop Informed Consent Forms and regulatory dossiers for initial submissions, amendme ...


  • MSD Sao Paulo, Brasil

    This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. · Under the ...


  • Fortrea Sao Paulo, Brasil

    The Ass CRM is accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight and impact on local regulatory and financial compliance, at a country operations level at the client in compliance with ICH GCP and country regulatio ...


  • ABBVIE Sao Paulo, Brasil

    **Purpose Statement**: · Provides medical/scientific strategic and operational input into medical affairs plans and activities, representing the Area/affiliates in coordination with the Global team. Within the Area, serves as Therapeutic Area expert in providing relevant scientif ...


  • MSD Sao Paulo, Brasil

    Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medi ...


  • MSD Sao Paulo, Brasil

    **Responsibilities include, but are not limited to**: · - The role is accountable for performance and compliance for assigned protocols and sites in a country; · - Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regul ...