Mumbai City, Maharashtra, India · Hybrid
Job Overview: Responsible for the preparation and review of aggregate safety, risk management, and signal detection documents. Perform report management activities and lead client communication for the assigned reports. …
Skills: Medical Writing, Pharmacovigilance, Signal Detection, Regulatory Submissions, Literature Search
Mumbai City, Maharashtra, India · On-site
What can you expect as a FedEx team member? Career Mobility and Development: When you join FedEx, you’re joining a team with possibilities that literally span the world—from opportunities for advancement and location tra…
Skills: Digital Optimization, A/B Testing, Personalization Strategies, Web Analytics, Adobe Target
Mumbai City, Maharashtra, India · On-site
About Us: A.P. Moller - Maersk is an integrated container logistics company working to connect and simplify its customers’ supply chains. As the global leader in shipping services, the company operates in 130 countries a…
Skills: LCL Product Management, CRM, PnL Management, Strategic Planning, Logistics Operations
Mumbai City, Maharashtra, India · Hybrid
$950k–$1200k/yr
About us WRI India, an independent charity legally registered as the India Resources Trust, provides objective information and practical proposals to foster environmentally sound and socially equitable development. Throu…
Skills: Video Production, Storytelling, Social Media Management, Script Writing, Adobe Premiere Pro
Mumbai City, Maharashtra, India · On-site
Project Role : Project Control Services Practitioner Project Role Description : Develop and execute end-to-end project management activities of an assigned program, project, or contracted service within a globally source…
Skills: SAP Concur, Project Management, Risk Identification, Risk Mitigation, Cross-functional Coordination
Mumbai City, Maharashtra, India · Hybrid
Position Summary: This is a full-time role with flexibility for some remote work. The Business Analyst will be responsible for analyzing business processes, gathering and documenting business requirements, and communicat…
Skills: Business Analysis, Scrum Master, Agile Methodology, Requirement Gathering, User Story Writing
Mumbai City, Maharashtra, India · On-site
Skill required: Workforce Data Admin - HR Service Delivery Designation: HR Service Delivery New Associate Qualifications:Any Graduation Years of Experience:0 to 1 years About Accenture Accenture is a global professional …
Skills: Workforce Data Administration, Communication, Written Communication, Deadline Management, Adaptability
Mumbai City, Maharashtra, India · On-site
Skill required: Workforce Data Admin - HR Service Delivery Designation: HR Service Delivery New Associate Qualifications:Any Graduation Years of Experience:0 to 1 years About Accenture Accenture is a global professional …
Skills: Workforce Data Admin, Communication, Written Communication, Time Management, Teamwork
Mumbai City, Maharashtra, India · On-site
Job title: Scientific Sales Executive Location: Jaipur About the job The Scientific Sales Executive is responsible for promoting pharmaceutical products to healthcare professionals (HCPs), building and maintaining relati…
Skills: Communication, Presentation Skills, Selling, Negotiation, Product Knowledge
Mumbai City, Maharashtra, India · Hybrid
Position Summary: This is a full-time role with flexibility for some remote work. The Business Analyst will be responsible for analyzing business processes, gathering and documenting business requirements, and communicat…
Skills: Business Analysis, Scrum Master, Agile Methodology, Requirement Gathering, User Story Writing
Mumbai City, Maharashtra, India · On-site
Job Description At EisnerAmper, we look for individuals who welcome new ideas, encourage innovation, and are eager to make an impact. Whether you’re starting out in your career or taking your next step as a seasoned prof…
Skills: Audit, Assurance, Financial Reporting, Client Relationship Management, Technical Accounting
Mumbai City, Maharashtra, India · Hybrid
Company:Marsh Risk Description: We are seeking a talented individual to be part of the Chief of Staff (CoS) organization for Marsh Risk This role will be based in Mumbai. This is a hybrid role that has a requirement of w…
Skills: CSR Strategy, Program Management, Stakeholder Management, Executive Communication, Budget Management
Mumbai City, Maharashtra, India · On-site
Job Title: Manager - Medical Science Business Unit: MACR Location: Mumbai At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your …
Skills: Medical Monitoring, Clinical Trial Design, Protocol Preparation, Clinical Study Report Writing, Patient Eligibility Assessment
Mumbai City, Maharashtra, India · On-site
We want someone who lives and breathes animation content, understands what makes kids and families laugh, connect, and stay hooked, and is always tuned into the latest trends in storytelling, internet culture, and visual…
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Mumbai City, Maharashtra, India · On-site
As a leading financial services and healthcare technology company based on revenue, SS&C is headquartered in Windsor, Connecticut, and has 27,000+ employees in 35 countries. Some 20,000 financial services and healthcare …
Skills: Cloud-Based Applications Sales, Relationship Building, Consultative Presentations, Contract Negotiation, Communication
Mumbai City, Maharashtra, India · On-site
Line of Service Advisory Industry/Sector Not Applicable Specialism Operations Management Level Associate Job Description & Summary At PwC, our people in project portfolio management focus on optimising project portfolios…
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Mumbai City, Maharashtra, India · On-site
Company Profile Morgan Stanley is a leading global financial services firm providing a wide range of investment banking, securities, investment management and wealth management services. The Firm's employees serve client…
Skills: SQL, Data Modelling, Stored Procedures, Performance Tuning, Teradata
Mumbai City, Maharashtra, India · On-site
We’re seeking someone to join our team as a Vice President into Risk, Regulatory & Resilience (EMIR Run The Bank Function) to oversee a team in Glasgow for managing the daily reporting risk of the EMIR transaction report…
Skills: EMIR Transaction Reporting, Risk Management, Regulatory Compliance, Root Cause Analysis, Data Analysis
Mumbai City, Maharashtra, India · On-site
Nomura Overview: Nomura is a global financial services group with an integrated network spanning approximately 30 countries and regions. By connecting markets East & West, Nomura services the needs of individuals, instit…
Skills: Market Risk Management, VaR Backtesting, SIMM Model Monitoring, FRTB, Python
Mumbai City, Maharashtra, India · Hybrid
About this role Job Description: Join our TECH & OPS-WTS-WEB CONTENT & OPERATIONS team as a publishing analyst, where you’ll play a key role in supporting web content publishing operations. This is a collaborative positi…
Skills: Content Publishing, Digital Content Management, HTML, CSS, Adobe Experience Manager
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Responsible for preparing and reviewing aggregate safety, risk management, and signal detection documents for global regulatory submissions. The role involves leading client communications, conducting scientific literature searches, and providing quality oversight for reports prepared by junior writers.
Requires a minimum of a first degree in life sciences and at least 3 years of pharmaceutical industry experience, with 2 years specifically in medical writing. Candidates must have a strong command of English and a solid understanding of Pharmacovigilance practices and ICH GCP guidelines.
Job Overview:
Responsible for the preparation and review of aggregate safety, risk management, and signal detection documents. Perform report management activities and lead client communication for the assigned reports. Assist other medical writers in their safety deliverables, act as a co-author for complex or large reports. Provide oversight and quality review of reports prepared by peers or junior associates. Conduct scientific literature searches and review for safety reports or routine surveillance activities. Ensure timely delivery of high-quality documents to internal customers and sponsors/clients. Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time.
Summary of Responsibilities:
Qualifications (Minimum Required):
Experience (Minimum Required):
Preferred Qualifications Include:
Physical Demands/Work Environment:
Learn more about our EEO & Accommodations request here.
Bringing life-changing benefits to patients faster
Fortrea (Nasdaq: FTRE) is a leading global clinical research organization (CRO) dedicated to providing innovative clinical development solutions to the life sciences industry. With over 30 years of clinical research experience, Fortrea has evolved from Covance and Labcorp into a pureplay CRO built for biotech, biopharma, medical device and diagnostic innovators. Fortrea collaborates with both emerging and established companies to deliver agile, fit-for-purpose full service (FSO), functional service (FSP) and hybrid solutions. Fortrea provides comprehensive Phase I-IV clinical trial management, clinical pharmacology, and consulting services, backed by deep experience in more than 20 therapeutic areas. Operating in approximately 100 countries, our diverse and talented team brings scientific rigor, operational excellence, and a strong investigator site network to every trial. By combining the best of our legacy experience with forward-thinking innovation, Fortrea brings predictability to clinical trial execution and helps transform aspirations into outcomes. Together, exceptional is possible. Learn more at Fortrea.com
Offices: Research Triangle Park, NC, US
