Pharmacovigilance Associate III
Bangalore, India, 560064
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.
- As Lead PV Professional, Medical Reviewer/Clinical Assessor within the ICSR management sub-function within Patient Safety Operations (PSO), the role in the Global Patient Safety & Pharmacovigilance department within Teva Global R&D (Research & Development) reports to the Head of ICSR Management;
- The Lead PV Professional, is responsible for all individual case medical review and inputs for reports originating from spontaneous and organized data collection.
- As Medical Reviewer/Clinical Assessor, support the case processors in medical judgement and MedDRA coding of adverse events. Responsible to assess company causality for all types of SAEs and contribute towards coaching and mentoring case processors towards clinical analysis for cases originating from organized data collection
How you’ll spend your day
- Perform medical review and clarification of Trial related (AE’s) & Post marketing Adverse Evets (ADR’s) including narrative content, queries, coding for events and lab reports, expectedness, seriousness, causality, labelling and medical assessment comments as applicable.
- Serve as a global safety physician and as an internal (within Teva) & external (to vendors) consultant to pharmacovigilance case processing groups. To have an active interactions with various other teams where there is a much need for medical judgements like labelling, causality, seriousness, MedDRA coding and other medical concepts etc.
- Maintain awareness of medical-safety-regulatory industry developments in order to participate in various trainings, workshops, product transitions, audit preparations, supporting any UAT activities and any knowledge transfer transition initiatives.
- Attend and conduct internal meetings with various stake holders and vendors on various queries/ clarification related to medical assessment concepts for better awareness amongst case processing groups.
- Provide support to EU Qualified Persons for Pharmacovigilance (QPPV) teams as applicable. Signal detections following preparation of Risk Management Programs, PSUR/DSUR surveillance activities, participate in Business Continuity Plans (BCP) as required.
Your experience and qualifications
- Medical Degree (MBBS with 5.5 years degree which includes internship of 1 year). Board approved/certified equivalent or 2 years post-graduation with valid medical license.
- Clinical medical experience of about 1-2 years and PV experience of at least 1 year as medical safety reviewer is recommended so as to fulfil the job role technical requirements on medical judgements.
- Project Management experience is an advantage.
- Fluent in English.
Enjoy a more rewarding choice
- Hybrid module
- Cab & Food facilities
- Opportunity to grow in a Global core pharma co,
Make a difference with Teva Pharmaceuticals
Teva Pharmaceuticals has been developing and producing medicines to help improve people’s lives for more than a century. We are committed to being a global leader in generic and specialty medicines with a portfolio of 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day. They are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products.
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