Pharmacovigilance Associate

Teva Pharmaceuticals; Ciudad de México; Presencial; MXN 749.484 - 1.124.227; Jornada completa

Descripción de la vacante

A global pharmaceutical company is seeking a Pharmacovigilance Associate in Mexico City. In this role, you will handle pharmacovigilance activities, assist with risk management plans, and ensure compliance with local regulations. The ideal candidate should have a Bachelor’s degree in a science field and at least 5 years of experience in the pharmaceutical industry, with strong skills in Microsoft Office and knowledge of pharmacovigilance IT systems. This is a full-time executive position.

Formación

• Minimum 5 years in Health Care or Pharmaceutical industry.
• At least 3 years of Pharmacovigilance experience.
• In-depth knowledge of FDA/Health Canada regulations.

Responsabilidades

• Perform pharmacovigilance activities within the North American PV unit.
• Review adverse event information for products.
• Participate in audits and inspections as needed.

Conocimientos

Proficiency with Microsoft Office

Knowledge of PV IT systems

Comfort with medical terminology

Educación

Bachelors of Science (Physics, Chemistry, Biology, etc.)

Herramientas

ARISg

Argus

Cognos

Descripción del empleo

Overview

Join to apply for the Pharmacovigilance Associate role at Teva Pharmaceuticals

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

• Core member of the safety team and is responsible for performing pharmacovigilance activities within the North American PV unit, in partnership with the Drug Safety Specialists/Pharmacovigilance Safety Specialist and Pharmacovigilance Managers/Director to receive and review adverse event information for pre and postmarketed products


• Should serve as a liaison with other Teva business units and function as a resource to the team.


• Review and confirm that accurate written records of all PV related activities are created, organized and maintained in compliance with all applicable global and local Standard Operating Procedures (SOPs), local Work Instructions (WIs) and ensure that they are up to date as required by regulations

How you’ll spend your day

• Assist and co-ordinate in the preparation of Risk Management Plans (with associated Risk Mitigation Strategies) as per the requirement of Health Canada.


• Responsible for handling local labelling updates (from the CCSI update to submission of safety variation) for all Teva medicinal products taking into consideration local regulatory timelines.


• Review and submit Periodic Safety Update Reports (PSURs) and the Canadian Annual Summary Report (ASRs) to Health Canada according to their regulations and guidance.


• Oversight of ADR reports downloaded from the Health Canada Vigilance Adverse Reaction Online Database and to ensure all Health Canada requirements are met.


• Assist and co-ordinate in preparation of Health Hazard Assessment on request.


• Other essential duties include drafting pharmacovigilance agendas and meeting minutes, accurately archiving pharmacovigilance documents.


• Participate in Pharmacovigilance audits and inspections as needed


• Contributes to process improvements and assist with CAPA review.


• Responsible to complete all training and SOP/WI reviews in a timely manner


• Creates and/or updates SOPs/WIs whenever processes and procedures are changed to comply with new regulations or to improve procedures or make them more efficient


• Support the manager in training new hires in PV on systems and processes relating to pharmacovigilance activities


• Participates in Pharmacovigilance local activities with case and workflow management


• Interfaces with other departments to facilitate information exchange as needed


• Responsible for leading local/regional projects when assigned


• Any other activities assigned by the Manager.

Your experience and qualifications

Education: Bachelors of Science (Physics, Chemistry, Biology, Biochemistry, microbiology, physiology, anatomy, pharmacology)

Experience:

• Minimum 5 years of Health Care or Pharmaceutical industry experience and at least 3 years of Pharmacovigilance experience


• Demonstrates proficiency with Microsoft Office Word, Excel, PowerPoint and Adobe Acrobat. Knowledge of PV IT systems such as ARISg, Argus, Cognos is an added advantage


• Comfort with PV IT systems and a familiarity with the ARISg safety database and medical terminology.


• In depth knowledge of the related FDA/Health Canada and international regulations

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

Join us on our journey of growth!

Seniority level

• Executive

Employment type

• Full-time

Job function

• Science

Industries

• Pharmaceutical Manufacturing