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Job Location | Bangalore |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Pharma / Biotech |
Functional Area | Sales / BD,Technical Writing |
EmploymentType | Full-time |
A career at our company is an ongoing journey of discovery: our 58,000 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.United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.Your Role:The Pharmacovigilance Business ProcessWriting Lead will be responsible for the creation of high-quality Pharmacovigilance (PV)-related Quality Documents (QDs) in alignment with the respective Process Owners. He/she will lead Business Process Management (BPM) strategy and implementation in Global Patient Safety (GPS) ensuring a fit for purpose BPM landscape and respective QDs. QDs encompass documents such as Policies, Standards, Standard Operating Procedures, and Working Instructions, as well as guidance documents.For our global PV QDs he/she will ensure content quality, compliance with applicable regulations and Company internal rules and timely availability by applying the BPM methodology.Key PV processes include but are not limited to areas like Aggregate Reports, Risk Management, Signal Management, Emerging Safety Issues, Urgent Safety Restrictions, Direct Health Care Professional Communication, Safety Communication, Post-Authorization Safety Studies and PV Quality System. In addition, he/she will ensure that PV requirements are fully implemented in non GPS QDs in adequate quality and compliance with applicable regulations through provision of high-quality reviews including a system and oversight for qualified reviewers/review on behalf of GPS.Provide leadership for implementation of automated solutions for structured content writing as well as leading implementation of structured content writing for PV Quality Management System related documents, for example the Pharmacovigilance System Master File.To fulfill the role of the Deputy for the GPS Head of Documentation and Training within the PV System and QPPV function. Who you are:
Keyskills :
business process managementstandard operating proceduresquality management systemms officepatient safetycontent writingrisk managementproblem solvingquality systemsstatements of work sow