Job Information
Teva Pharmaceuticals Pharmacovigilance Associate in Jakarta, Indonesia
Pharmacovigilance Associate
Date: Apr 23, 2024
Location:
Jakarta, Indonesia, 13710
Company: Teva Pharmaceuticals
Job Id: 55482
Who we are
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
We are seeking an experienced Pharmacovigilance (PV) professional to join our dynamic business at Teva. As the Pharmacovigilance Associate, you will be managing the day-to-day operations within the Indonesia PV department. Your key responsibilities include ensuring quality and compliance of all PV deliverables and you will be involved in training, business development, audits/inspections, and the management of the outsourced vendor relationships.
For those currently at Senior PV Associate level, this is a great opportunity for you to step up and lead PV for Indonesia. Additionally, you will have the opportunity to lead and participate in regional PV projects, working with APAC PV team and other global PV departments. At the APAC level, you will also have oversight of all aspects of PV compliance.
How you’ll spend your day
Act as the Qualified Person for PV (QPPV) / Local Responsible PV person according to the local country requirements, and when/if required acts as back-up Local Safety Officer (LSO) to selected APAC countries.
Ensure the collection, intake, processing, quality control and expedited regulatory reporting of adverse events from all sources in compliance with applicable procedures and national requirements.
Responsible for local PV vendor management.
Responsible for completing periodic reconciliation with internal and external stakeholders.
Responsible for the preparation and maintenance of the local PSMF.
Support the preparation and management of PV budget.
Responsible for local PSUR planning and ensures PSURs and DSURs are submitted to the local regulator.
Responsible for all local Risk Management activities, including the implementation of risk minimisation activities from local or global Risk Management Plans (RMP) in agreement with local authority.
Draft any Specific Annex to local RMPs and makes sure RMPs are submitted to local authority timely and in accordance with local regulations.
Support Global PV Agreement Team when required for any local negotiations of PV agreements with local 3rd parties.
Supports the global compliance team with 3rd party PV audits of local partners.
Maintains understanding of relevant Global and Regional SOPs, Work Instructions (WIs) and supports the Regional PV Manager with the writing and maintenance of Regional SOPs/Work Instructions (as applicable).
Provides PV trainings per risk-based assessment to Teva employees & to applicable local 3rd parties. This includes coordination of training programs and ensuring local and global standards are met.
Notifies and coordinates with Regulatory Affairs personnel on the any safety labelling changes and submits safety related notifications to local health authority.
Communicates and works with local interfaces (Medical Affairs, Marketing, QA, Commercial) to ensure PV processes and activities are covered in various company projects and activities.
Experience in PV inspections and audits, including the management and implementation of the CAPA process.
Ensure the drafting, establishment, implementation and follow up on CAPA plans.
Your experience and qualifications
Bachelor’s Degree in Life Sciences/ Nursing / Pharmacy or related disciplines
Minimum 3 years of relevant experience within the pharmaceutical industry – ideally in PV, Reg Affairs, Medical Information or Medical Affairs
Strong understanding and experience in PV at a senior level in the Indonesia market (and other APAC markets, if applicable) and acting as Locally Qualified Person in Indonesia
Knowledge of ICH guidelines and other global guidelines
Experience with global safety database
Strong stakeholder management and communications skills in particular managing and influencing regulators, executives and cross functional leaders
A self-starter with a hands-on approach and a strong “can-do” attitude, with the ability to work independently and be self-motivated
Results oriented, and self-motivating with a strong drive to meet and exceed all targets
Possess a high level of business ethics, integrity, and professionalism
Make a difference with Teva Pharmaceuticals
Please upload your CV and Cover Letter.
Please note that only shortlisted candidates will be contacted.
Reports To
Pharmacovigilance Manager
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