Job title: Safety Medical Writer
Company: Merck Group
Job description: 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 wo
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: Support Global Patient Safety (GPS) Safety Scientists and Safety Strategy Leads with regards to safety medical writing (SMW) activities. Authora wide range of pharmacovigilance documents including but not limited to various Periodic Safety Reports, Signal Evaluation Reports, Safety Strategy and Core Benefit-Risk Documents, Risk-Management Plans, Patient Safety Narratives and Health Hazard Reports. Author responses to Health Authorities queries (ad-hoc queries, queries following submission of PBRER/PSUR, such as PRAC inquiries, etc.). Effectively and clearly communicate technical, medical, and scientific information in critical submission and internal PV documents in order to deliver high quality reports within the specified timelines. Review (both self- and peer) of SMW deliverables for data accuracy, consistency, and ensuring alignment with the processes, templates and regulations. Participate in meetings related to key PV activities. Collaborate cross functionally for continuous improvement of standards and best practices for medical writing. Who youare: Graduate degree or equivalent job experience with comprehensive pharmacovigilance knowledge of theories, principles and concepts, MD/PhD or advanced science degree. Excellent written and spoken English (including medical terminology) with a familiarity with AMA style guide. Profound pharmacovigilance experience (5 to 9years’ experience in drug/patient safety) required. Demonstrated experience in Periodic Safety Reports of interpretation & presentation of aggregate safety data. Strong knowledge of regulations and guidelines (FDA, EMA, ICH, EU GVP, etc.). Experience in signal management, benefit-risk assessment, literaturesurveillance is beneficial. Proven experience in ability to consistently produce documents of high quality and express complex data in a concise and easy-to-read way. Comprehensive experience in working in cross-functional, global teams, across different regions and time zones. A flexible attitude with respect to work assignments and new learning readily adapts to changes. 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 We are committed to promoting a diverse and inclusive workforce. Applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.
Location: Bangalore, Karnataka
Job date: Sun, 23 Jan 2022 23:36:39 GMT
Apply for the job now!