Local Pharmacovigilance Officer

hace 17 horas

Quito Sitero LLC Freelance

Local PV Officer – JOB DESCRIPTION

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. 

Job Title: Local PV Officer

Location: Ecuador

Function:  Drug Safety

DESCRIPTION:

Local PV Officer works collaboratively with Global PV staff, and cross-functional colleagues/teams for pharmacovigilance activities and ensuring regulatory compliance according to the applicable regional and national laws for all medicinal product(s) and territory(ies) for Sitero is responsible. The primary function is to perform translations of the incoming information (safety / non-safety), managing and supporting pharmacovigilance activities such as conducting non-English follow ups for gathering safety information, local case report distributions & NCA submissions.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Perform translations and/or quality review of the translations (manual / automated) of the incoming information (safety / non-safety).
  • Perform accurate, complete, and timely translation of safety-relevant information
  • Ensure compliance with international and local guidelines (like GDPR & and applicable data protection laws) into account.
  • Should have access to the reports of suspected adverse reactions and assist in monitoring the regulatory submissions.
  • Perform non-English follow-ups via phone, email etc.
  • Support in preparation of submission packages (local forms in local languages) for local Health Authority case submissions.
  • Keep abreast of national pharmacovigilance and regulatory affairs regulations.
  • Receive and handle medical information enquiries from patients and health care professionals.
  • Must be contactable during business hours.
  • Demonstrate knowledge and ensure compliance with current global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), Sitero SOPs and quality standards.
  • Stay current with international pharmacovigilance requirements and guidelines.
  • Foster an environment of collaboration, team building, and continuous improvement.

EDUCATION AND EXPERIENCE REQUIRED:

  • Fluent in source and target language (native or near-native in target language)
  • Excellent written communication skills
  • Trained in pharmacovigilance terminology
  • Documented PV training (e.g., SOP training, GVP awareness)
  • Understanding of medical terminology (medical degree not required, but experience is)

PREFERRED SKILLS:

  • Preference for a minimum 2 years relevant medical, scientific/clinical, or pharmaceutical experience.
  • Competent knowledge of good pharmacovigilance practices. Competent knowledge of US and EU pharmacovigilance regulatory requirements.
  • A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.
  • Experience in the review of relevant safety information from all sources and analysis of safety data.
  • Knowledge of global clinical and post-marketing safety regulations, guidance documents, and reporting processes.
  • Expertise with MedDRA, XEVMPD coding and safety database systems.
  • Review and contribute to the development and implementation of new SOPs, work instructions, guidelines, documents and other tools pertaining to safety.
  • Exhibit excellent organizational, presentation and communication (verbal and written) skills.

EMPLOYMENT TYPE:

Contractual, As-Need basis

COMMITMENTS:

  • Availability during local business hours.

DISCLAIMER: 

Sitero is an equal opportunity employer and welcomes all job applicants.  All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

  • Local Pharmacovigilance Officer

    hace 17 horas

    Quito Sitero LLC Freelance

    The Local PV Officer works collaboratively with Global PV staff and cross-functional colleagues/teams for pharmacovigilance activities and ensuring regulatory compliance according to the applicable regional and national laws. · ...

  • Local Pharmacovigilance Officer

    hace 11 horas

    Quito, Ecuador Sitero LLC Freelance

    Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas. · We deliver high-touch services to ensure the safety of all stakeholders across the clinical researc ...

  • Medical Representative Loja, Ecuador

    hace 3 semanas

    Quito Procter & Gamble

    We are looking for a passionate Medical Sales Representative who is eager to drive our brands and make a positive impact on patients, healthcare professionals and pharmacies. · ...

  • Asistente de Proyecto Urban Futures

    hace 4 semanas

    Quito Hivos OTHER

    Se requiere un asistente de proyecto para apoyar a la oficina de Hivos Ecuador en Quito con actividades contables administrativas y logísticas. · ...

  • Workplace Experience Coordinator

    hace 2 semanas

    Quito Verndale

    We are looking for an energetic, highly-organized, service-oriented, and proactive Workplace Experience Coordinator to ensure the smooth day-to-day operations of our office and create a welcoming, efficient, and engaging workplace environment for our team. · Greet visitors and ve ...

  • UNOPS Senior Legal Associate

    hace 1 mes

    Quito UNHCR, the UN Refugee Agency Full time$20.000 - $28.000 per year

    The Senior Legal Associate assists an office in providing quality, timely and effective protection responses to the needs of populations of concern. · 4 years relevant experience with High School Diploma; or 2 years relevant work experience with Bachelor or equivalent or higher. ...

  • Marketing Intern Ecuador

    hace 1 mes

    Quito Mondelēz International Internship$10.080 - $14.400 per year

    This internship involves managing purchases for Pbs · and meals in all countries of WACAM. · ...

  • Information Technology Support Engineer

    hace 20 horas

    Quito OurSupport

    + Configure and troubleshoot customers' desktop or laptop computers+ Reproduce customer environment and run tests+ Manage electronic tickets efficiently+ Troubleshoot software hardware network issues + Work onsite in Quito ...

  • Intern Modern Trade Ec

    hace 4 semanas

    Quito Mondelēz International Internship

    Reportería de ejecución semanal de equipos propios y externos en la industria del comercio moderno. · ...

  • UNOPS Registration Assistant

    hace 4 semanas

    Quito UNHCR, the UN Refugee Agency Full time

    The Registration Assistant is a member of the registration team and is supervised by a more senior colleague who normally reports directly to the Registration Officer. The incumbent is responsible for supporting all activities related to registration which may also include functi ...

  • Call for Application

    hace 4 semanas

    Quito Vacancies at IOM Indonesia

    The Driver will undertake driving duties for assigned IOM office vehicles. · ...

  • MICE & Groups Specialist

    hace 1 semana

    Quito Abercrombie & Kent Latin America

    Abercrombie & Kent Mexico is looking for a MICE & Groups Specialist in Mexico City. · ...

  • Staff Accountant

    hace 14 horas

    Quito Industry FinTech

    We're growing fast and building a high-performing team in Ecuador. · Maintain financial records reports and general ledger accounts · Prepare journal entries reconciliations and support the monthly close · Assist in building budgets and forecasting financial performance · Manage ...

  • UNOPS Community-Based Protection Assistant

    hace 4 semanas

    Quito UNHCR, the UN Refugee Agency Full time

    The Community-Based Protection Assistant supports UNHCR Ecuador's Multi-Year Strategy by implementing community-based protection standards in field delivery. They work with communities of concern to identify risks and leverage capacities for self-protection. · - Through relations ...

  • Fin/Ops Analyst

    hace 6 días

    Quito Industry FinTech

    We are looking for a detail-driven analyst to strengthen our finance and operations backbone. · Native or fully fluent English (written and spoken). · Background in Finance, Accounting, Business, or Legal Studies. · ...

  • Workshop Mechanic

    hace 2 meses

    Quito Wärtsilä $15.000 - $35.000 per year

    We are looking for a Workshop Mechanic to join our team in Quito. · Perform and complete the technical tasks in accordance with instructions provided by the Workshop Team Leader. · Support during WS services, repairs and special services on equipment. · ...

  • Risk Management Country Officer

    hace 2 días

    Quito Citi Full time

    The Risk Management Country Officer (RMCO) serves as the single point of contact for franchise-level Risk matters in each country. They oversee all Risk-related regulatory and governance matters across all legal entities in each country and ensure timely escalation and resolution ...

  • Fin/Ops Assistant

    hace 20 horas

    Quito Industry FinTech

    +We're a passionate fast-paced team dedicated to innovation and growth. · + · Maintain update and reconcile cash projection reports for financial planning. · + ...

  • Lead, Billing Specialist

    hace 2 días

    Quito North Highland

    We're seeking a Lead Accounts Receivable Specialist in our Quito, Ecuador office to help us take vision to value and create lasting impact. · ...

  • Accounting & Payroll Specialist

    hace 6 días

    Quito Workers Benefit Fund

    We are seeking an Accounting & Payroll Specialist to support day-to-day financial operations, payroll processing, and system administration across the U.S. and Ecuador. · ...

  • Trade MKT Intern

    hace 2 semanas

    Quito Mondelēz International

    This is an internship opportunity with Mondelēz International in Quito. · You will support customer plans by developing strategies and tactics for growth,Leads trade marketing part of category annual plans. · Follows up competition's commercial activity in order to detect busines ...