Pharmacovigilance Associate III

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 operations 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 Operations;  
• 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 active interactions and provide inputs with other functions for topics related to labelling, causality, seriousness, MedDRA coding and other medical concepts etc. 
• Maintain awareness of medical-safety-regulatory industry developments to participate in trainings, workshops, product transitions, audit preparations, supporting UAT activities and knowledge transfer transition initiatives. 
• Support audits and inspections for case processing & medical review aspects
• Create and update Standard Operating Procedures and Working Instructions to ensure optimal operational management of ICSR and related activities
• Maintain regular communication with the external vendor regarding medical review workflow, process updates and maintain a necessary oversight to address any gaps/risks.
• Perform routine quality check to measure the medical review quality for vendor and in-house team
• 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. 
• Manage paid time off, appropriate backups for the team to ensure smooth operations with minimal disruption.

• Qualification - MBBS OR MD
• Experience - 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. 

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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.