Job Description

Who are we?

Teva is a global pharmaceutical leader and the world\'s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world\'s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we\'ve built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!



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

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.

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

Function

Regulatory Affairs

Sub Function

Pharmacovigilance

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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.

Teva Pharmaceuticals