Safety Writing Assistant Ii
1 month ago
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
**Job Description**:
Perform allied activities such as generation of outputs/reports from the databases or safety systems, distribution of data requests, sales data calculations, regulatory website searches, collating report planning materials, etc. Author parts of various safety reports for global regulatory submissions, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Development Safety Update Reports, Risk Management Plans, and other documents as assigned. Develop the assigned report parts, examples of which may include sections with majorly pre-populated template text, re-use of content from other documents, or low to medium complexity of safety analyses. Review and annotate line listings, prepare case narratives or data summaries, and present data per approved strategy. Participate in comment resolution discussions for the assigned sections. Support medical writers in signal detection activities, including data cleaning, review and annotation of line listings, creating supporting material for signal review meetings, and preparing parts of signal reports. Support the preparation of ad hoc reports such as safety issue analysis reports, and justification/supporting documents for label updates. Write sections of Common Technical Document Summaries including Non Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned. Conduct literature searches for authoring various types of reports. Review the search outputs for selection of articles potentially relevant for inclusion in safety reports. Prepare abstracts or summaries of the selected articles. Perform any additional activities as per the project requirement or manager’s discretion on completion of relevant training.
Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables Ensure compliance of operations with governing regulatory requirements. Create, maintain and assume accountability for a culture of high customer service.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our
Privacy Statement
.
-
Safety Writing Assistant Ii
4 weeks ago
Mumbai, Maharashtra, India Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Urgent Opening for Commis Ii
3 hours ago
Mumbai, India Client of Peoplelan LLP Full time**Key Responsibilities**: - Food Preparation: Assist in the preparation of ingredients and dishes according to recipes and established standards. This includes chopping vegetables, marinating, and assembling dishes under the guidance of senior chefs. - Cooking: Assist in cooking and baking various dishes, ensuring they are cooked to perfection and...
-
Operator Assistant Ii
5 days ago
Mumbai, India Halliburton Full timeWe are looking for the right people — people who want to innovate, achieve, grow and lead. We attract and retain the best talent by investing in our employees and empowering them to develop themselves and their careers. Experience the challenges, rewards and opportunity of working for one of the world’s largest providers of products and services to the...
-
Assistant to Certifier
4 weeks ago
Navi Mumbai, India Peterson Recruitment Full timeAn exciting opportunity has arisen at **Certifications** in **Navi Mumbai, India** for **ASSISTANT TO CERTIFIER - FOOD SAFETY.** Are you committed to **integrity, quality, and a self-driven, systematic, service-oriented person** and do you want to be part of our international network? Then we are looking for you! **Tasks and Responsibilities**: -...
-
Fire & Safety Technician
2 days ago
CBD Belapur, Navi Mumbai, Maharashtra, India SHIELDON FIRE AND SAFETY (OPC) PVT. LTD Full time**Duties**: - Always follow instructions assigned to you. - Installing and testing products, equipment, and machinery and providing instructions to clients on the proper usage of their products. - Maintaining professional behavior with clients. - Follows installation and operation manuals. - Responds to service requests and repairs products. - Uses...
-
Tender Executive
2 weeks ago
Ghansoli, Navi Mumbai, Maharashtra, India Universal Fire and Safety Services Ltd. Full time**Key Responsibilities**: - **Tender Identification and Analysis**: - Monitor various tender portals and sources for new tender opportunities. - Analyze tender documents to understand the requirements, specifications, and conditions. - **Tender Preparation**: - Coordinate with various departments (technical, legal, finance, etc.) to gather necessary...
-
Senior Safety Writer
3 weeks ago
Mumbai, India Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Senior Safety Writer
3 weeks ago
mumbai, India Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Service Supervisor Ii-subsea Safety Systems
2 days ago
Mumbai, India Halliburton Full timeWe are looking for the right people — people who want to innovate, achieve, grow and lead. We attract and retain the best talent by investing in our employees and empowering them to develop themselves and their careers. Experience the challenges, rewards and opportunity of working for one of the world’s largest providers of products and services to the...
-
Service Supervisor Ii-subsea Safety Systems
3 hours ago
Mumbai, India Halliburton Full timeWe are looking for the right people — people who want to innovate, achieve, grow and lead. We attract and retain the best talent by investing in our employees and empowering them to develop themselves and their careers. Experience the challenges, rewards and opportunity of working for one of the world’s largest providers of products and services to the...
-
Safety Officer
4 weeks ago
Mumbai, India Gubbi Civil Engineers Full timeWe have job opening for the **Saftey Officer** with below job responsibilities. **Location: Mumbai** **Total Experience: 1-4 yrs.** **Responsibilities as Safety Officer**: - Conduct Toolbox Talk on daily basis and maintain proper records. - Act as a coordinator at all levels of management regarding safety and assist them in reviewing and modifying...
-
Safety Officer
1 week ago
Mumbai, India Ambuja Neotia Group Full timeExtensive knowledge of locality processes and procedures to execute a project. Have a good understanding of construction and engineering technology **Responsibilities**: - Continuous inspection of project sites, to ensure a hazard-free environment. - Assessment and approval of subcontractor safety plans. - Verification of tools and equipment to ensure...
-
Safety Writer
3 weeks ago
mumbai, India Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Safety Writer
3 weeks ago
Mumbai, India Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Safety Writer
4 days ago
Mumbai, India Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Pharmacovigilance Physician Ii
1 month ago
Mumbai, India PrimeVigilance Full timeCompany Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...
-
Safety Writer
1 month ago
Mumbai, India Fortrea Full timePerform allied activities such as data collection for report planning, developing strategy, and leading kick-off meetings and round table discussion for comment resolution. Write various safety reports (or part of such reports) for global regulatory submissions, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports,...
-
Service Supervisor II-Subsea Safety Systems
2 days ago
Mumbai, India Halliburton Full timeWe are looking for the right people — people who want to innovate, achieve, grow and lead. We attract and retain the best talent by investing in our employees and empowering them to develop themselves and their careers. Experience the challenges, rewards and opportunity of working for one of the world’s largest providers of products and services to the...
-
Service Supervisor II-Subsea Safety Systems
5 days ago
Mumbai, India Halliburton Full timeWe are looking for the right people — people who want to innovate, achieve, grow and lead. We attract and retain the best talent by investing in our employees and empowering them to develop themselves and their careers. Experience the challenges, rewards and opportunity of working for one of the world’s largest providers of products and services to the...
-
Service Supervisor II-Subsea Safety Systems
5 days ago
mumbai, India Halliburton Full timeWe are looking for the right people — people who want to innovate, achieve, grow and lead. We attract and retain the best talent by investing in our employees and empowering them to develop themselves and their careers. Experience the challenges, rewards and opportunity of working for one of the world’s largest providers of products and services to the...