The opportunity
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.
How you’ll spend your day
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.
