Job title: EVDD-0, Safety Project Manager
Company: Merck Group
Job description: A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the wo
A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. The Safety Project Manager, Analyst, GPS Operations is a key role in providing support to the GPS department for Periodic Safety Reports Management, and other PV tasks. The Safety Project Manager will work in a team of experts with an open communication culture and oversee variety of all PV project management tasks. This role requires safety-related expertise, with an ability to understand and comply with general pharmaceutical industry rules, regulations, company processes, SOPs and Work Instructions, particularly in connection with investigational Drug Safety and Pharmacovigilance for clinical studies, as well as post-marketing activities. Key responsibilities of the Safety Project Manager include but not limited to: . Project Management of all Merck Pharmacovigilance activities include but not limited to: o Activity Planning, Defining Scope, Developing Schedules and Time Estimations o Documentation, including creating of Charts and Presentations o Process Improvement Initiatives o Monitoring and Reporting Progress o Working with Vendors . Prepare and coordinate safety activities throughout the process lifecycle for post-marketing periodic safety reports (PSR): o Periodic Safety Updates Reports (PSURs) o Periodic Benefit Risk Evaluation Reports (PBRERs) o Post-marketing Line Listings o Periodic Adverse Drug Experience Report (PADER). . Assistance in Signal Management Process Activities. . Tracking and oversight of safety commitments and quality issues from preliminary and final health authority assessments reports, as well as commitments to Marketing Authorization, if applicable. . Oversight of timelines, tracking and monitoring of the process steps as per established flow in a dedicated IT tool. . Support the maintenance of the PSR data within the PV IT Tool (RESCOM). . Plan organize and conduct meetings related to key PV activities such as kick-off, safety data review, adhoc meetings with internal and external stakeholders, including generation of well written and accurate meeting protocols. . Retrieve data for various safety reports from internal and external stakeholders, and business partners, including monitoring the contributions delivery timelines and follow-up, as required, to meet the report scheduled timelines. . Ensure thorough review of safety documents for data accuracy, consistency, correct use of grammar and consistency with the SOPs, Templates, and Style Guide prior to sharing with other stakeholders for review. . Prepare distribution of safety reports to the recipients as per processes, timelines, and regulatory requirements. . Collect data for the submission dates of safety reports, as applicable. . Provide input for audit requests, if needed. What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life! Curious Apply and find more information at
Expected salary:
Location: Bangalore, Karnataka
Job date: Thu, 11 Aug 2022 22:30:31 GMT
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