Safety Writer
2 days 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.
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
Efficiency in conducting literature searches for authoring various types of reports
Author/review various safety reports (or part of such reports) for global regulatory submissions for Fortrea’s clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Bridging reports and other clinical documents as assigned.
Perform/review Signal detection activities
Author/ review RMP, ad hoc reports, Safety Update reports, Benefit-Risk Evaluation, CCDS supporting document, ACOs, Addendum reports
Perform allied activities like: Generation of line listings and summary tabulation, CFIs CFCs
Search literature databases for relevant information, recommend label changes, author proposed label text and prepare supporting/justification document
Author/review SOPs/WIs/process documents or sections as applicable
Impart/conduct Trainings for peers and team members
Any additional activities as per the project requirement or manager’s discretion on completion of relevant trainings
**Qualifications**:
Bachelor’s/Master’s degree in Pharmacy/related science area OR Bachelor’s degree in Medical Science
Experience
At least 3 years of experience in the pharmaceutical industry, with at least 2 years of it in medical writing
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 Writer
1 week 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. Conducting operations in...
-
Safety Writer
4 days ago
Navi Mumbai, Maharashtra, India Fortrea Full time**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...
-
Safety Writer
2 weeks 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,...
-
Safety Writer
1 week 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. Conducting operations in...
-
Safety Writer
17 hours ago
mumbai, India Fortrea Full timeJob 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...
-
Principal Safety Writer
4 days 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...
-
Medical Writer Ii
1 week ago
Navi Mumbai, Maharashtra, India Fortrea Full time**Job Overview**: Lead writer responsible for preparation of clinical study protocols and clinical study reports (CSRs), and other clinical documents as needed. Provides support to more experienced writers with the preparation of complex clinical documents. Interpretation of clinical, pharmacokinetic, pharmacodynamic and statistical results as appropriate....
-
Medical Writer Ii
4 days ago
Navi Mumbai, Maharashtra, India Fortrea Full time**Job Overview**: Lead writer responsible for preparation of clinical study protocols and clinical study reports (CSRs), and other clinical documents as needed. Provides support to more experienced writers with the preparation of complex clinical documents. Interpretation of clinical, pharmacokinetic, pharmacodynamic and statistical results as appropriate....
-
Safety Writing Assistant Ii
2 days 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...
-
Expert Regulatory Writer
1 week ago
Mumbai, Maharashtra, India Novartis Full time ₹ 12,00,000 - ₹ 36,00,000 per yearRole Overview: As a Medical Writer at Novartis Healthcare Private Limited, you will be responsible for writing, reviewing, and managing the production of high-quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. Your role will also involve providing authoritative documentation-related...