Mgr Pharmacovigilance

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 Pharmacovigilance Manager, 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;  
• Responsible for having an overview of ICSR process and quality and ensure the case processing is aligned to global regulatory requirements of compliance & case quality standards.
• Required to continuously work on the constant inputs for process simplification of ICSR management to related functionalities like process excellence, quality metrics and monitoring and systems and innovations team and to liase with stakeholders with PV units and ensure alignment between units.
• Should have global oversight of case processing activities, provide guidance to LSO’s and support relevant stakeholders to get aligned to PSO ICSR standards for managing AE’s and SAEs.

• To directly manage, oversee and lead a team of professional experts and individual contributors.
• To coach/ mentor and inspire team members to achieve their full potential.
• To ensure the team’s activities are adequately resourced, tracked, monitored and executed in accordance with defined timings to ensure patient safety and regulatory compliance is delivered in an operationally excellent way, and in conjunction with Teva’s core values, goals and objectives
• Responsible for process overview of ICSRs and its related activities globally and support LSO to have local regulations in alignment with global standards for all Teva products.
• To contribute/support the generation and maintenance of Standard Operating Procedures (SOPs) and Working Instructions (WIs) to ensure optimal operational handling of ICSR and its related activities
• Attend and conduct internal meetings with various stake holders and vendors on various. queries/clarification related to ICSR processing for better awareness amongst case processing groups.
• To supervise and oversee the responsibilities of case processing compliance with respect to various Partners/Regulators through effective decision making. Training compliance, case processing quality, audit/inspections preparedness and ensuring no deviations are in the process.
• To support any Global led guidance to world-wide LSOs wrt local ICSR processes and to foster greater collaboration through Working Groups, LSO Forums and other opportunities.
• Act as process expert with in ICSR processing team, and to ensure the case processing related activities performed as per the requirements from global regulatory authorities.
• To have active interactions with clinical assessors to ensure case processing and medical review activities are being performed correctly for topics related to labelling, causality, seriousness, MedDRA coding and other medical concepts etc.
• Being part of Global Pharmacovigilance Leadership teams representing PSO team in inspections and audits when required globally and support LSO/Vendor/Partners with local audits/inspections.

• Qualification - BDS OR MBBS which includes internship of 1 year.
• Experience - Minimum of 10 years of Biopharmaceutical/CRO industry experience in pharmacovigilance, including a large international organization.
• Lean Six sigma certification.

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.