Safety Specialist
6 days ago
Transforming Drug Development
CSS Fortrea Scientific Pvt Ltd is seeking a highly motivated Safety Writer to join our team. As a leading global contract research organization, we provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.
Key Responsibilities:
- Implement and promote use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures.
- 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 our 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.
About Us:
CSS Fortrea Scientific Pvt Ltd 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.
-
Automotive Safety Specialist
2 weeks ago
Pune, Maharashtra, India Magna Full timeAbout the RoleWe are seeking a skilled Automotive Safety Specialist to join our team at Magna Electronics. As a key member of our active safety team, you will be responsible for developing and implementing innovative safety technologies that revolutionize the automotive industry.Your ResponsibilitiesAs an Automotive Safety Specialist, you will:Design and...
-
Clinical Safety Specialist
6 days ago
Pune, Maharashtra, India Lifelancer Full timeJob Title: Clinical Safety SpecialistJob Summary:We are seeking a highly motivated Clinical Safety Specialist to join our team at Lifelancer. As a Clinical Safety Specialist, you will be responsible for implementing and promoting the use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard...
-
Safety Specialist
1 week ago
Pune, Maharashtra, India CSS Fortrea Scientific Pvt Ltd Full timeTransforming Drug DevelopmentCSS Fortrea Scientific Pvt Ltd is seeking a highly motivated and detail-oriented Safety Specialist to join our team. As a leading global contract research organization, we provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across...
-
Pharmaceutical Safety Specialist
2 weeks ago
Pune, Maharashtra, India Capgemini Engineering Full timeJob SummaryThe Pharmaceutical Safety Specialist is responsible for overseeing and managing pharmacovigilance activities to ensure compliance with regulatory requirements and to enhance the safety profile of pharmaceutical products. This role involves analyzing adverse drug reactions, managing risk assessments, and providing strategic guidance to ensure...
-
Pharmaceutical Safety Specialist
2 weeks ago
Pune, Maharashtra, India Capgemini Engineering Full timeJob SummaryThe Capgemini Engineering team is seeking a highly skilled Pharmaceutical Safety Specialist to join our team. As a key member of our pharmacovigilance team, you will be responsible for ensuring the safety of our pharmaceutical products by analyzing adverse drug reactions, managing risk assessments, and providing strategic guidance to regulatory...
-
Clinical Safety Specialist
1 week ago
Pune, Maharashtra, India Lifelancer Full timeJob SummaryAs a Clinical Safety Specialist at Lifelancer, you will be responsible for implementing and promoting the use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures. You will assume accountability for the deliverables and ensure compliance of operations with...
-
Clinical Safety Specialist
4 days ago
Pune, Maharashtra, India Lifelancer Full timeKey Responsibilities:As a Clinical Safety Specialist at Lifelancer, you will be responsible for implementing and promoting the use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures. You will assume accountability for the deliverables and ensure compliance of...
-
Pune, Maharashtra, India Philips Full timeJob Title: Product Safety and Risk Management SpecialistAbout the Role:We are seeking a highly skilled Product Safety and Risk Management Specialist to join our team at Philips. As a key member of our Post Market Surveillance (PMS) and Risk Management (RM) team, you will be responsible for ensuring the safety and quality of our medical devices.Key...
-
Product Safety Inspector
6 days ago
Pune, Maharashtra, India Schindler Group Full timeWe're Looking for a Quality Assurance SpecialistThe Quality Assurance Specialist creates added value through conducting Schindler Acceptance Inspection Standard (SAIS) and CPSI inspections to ensure conformance to Schindler product quality and safety standards.Key responsibilities include:• Conducting acceptance inspections and tests to determine whether...
-
Pune, Maharashtra, India Philips Full timeJob Title: PMS & RM SpecialistJob Description:We are seeking a highly skilled Product Safety and Risk Management Specialist to join our team at Philips. As a key member of our organization, you will be responsible for managing activities related to product safety surveillance and risk management, ensuring that our medical devices meet the highest standards...
-
Safety Specialist
2 weeks ago
Pune, Maharashtra, India Lifelancer Full timeJob Title: Safety WriterAs a leading global contract research organization (CRO), Fortrea is committed to delivering high-quality clinical development solutions to pharmaceutical, biotechnology, and medical device customers. We are seeking a skilled Safety Writer to join our team.Key Responsibilities:Implement and promote the use of consistent, efficient,...
-
Safety Specialist
2 weeks ago
Pune, Maharashtra, India CSS Fortrea Scientific Pvt Ltd Full timeTransforming Drug and Device DevelopmentAt CSS Fortrea Scientific Pvt Ltd, we're revolutionizing the development process to ensure the swift delivery of life-changing ideas and therapies to patients in need. As a leading global contract research organization (CRO), we provide pharmaceutical, biotechnology, and medical device customers with a wide range of...
-
Product Safety and Risk Management Specialist
2 weeks ago
Pune, Maharashtra, India Philips Full timeAbout the Role:This is an exciting opportunity to join Philips as a Product Safety and Risk Management Specialist, where you will play a critical role in ensuring the safety and quality of our medical devices.Key Responsibilities:Manage activities related to product safety surveillance and risk management, including review of data from clinical studies and...
-
Functional Safety Specialist
2 weeks ago
Pune, Maharashtra, India Chetak Technology Ltd Full timeJob Title: Functional Safety EngineerBajaj Auto has been a pioneer in developing powerful, sustainable, and affordable vehicles for over 75 years now. In late 2019, we started the Urbanite business, as a result of which we were able to launch an EV avatar of our popular, flagship market leader - Chetak. With endless advancement opportunities and an intent to...
-
Health and Safety Specialist
2 weeks ago
Pune, Maharashtra, India Cummins Inc. Full timeJob SummaryCummins Inc. is seeking a skilled Health, Safety and Environmental (HSE) professional to join our team. As an HSE Technician, you will play a critical role in ensuring the safety and well-being of our employees and the environment.Key Responsibilities:Assist in the review and sustainability of Health, Safety and Environmental Management...
-
Pune, Maharashtra, India Philips Full timeJob Title: Product Safety and Risk Management SpecialistJob Description:You will be responsible for managing activities related to product safety surveillance and risk management, including review of data from clinical studies and spontaneous complaints for accuracy, completeness, regulatory reporting, and potential safety issues. As a liaison between...
-
SMTE- Active Safety Specialist
6 days ago
Pune, Maharashtra, India Tata Motors Full timeJob SummaryAt Tata Motors, we are seeking a highly skilled Active Safety System Engineer to join our team. As an Active Safety System Engineer, you will be responsible for designing, developing, and implementing safety systems for our vehicles.Key ResponsibilitiesDesign and develop safety systems for our vehicles, including ABS and ESP systems.Implement...
-
Product Safety and Risk Management Specialist
2 weeks ago
Pune, Maharashtra, India Philips Full timeJob Title: Product Safety and Risk Management SpecialistJob Description:You will be responsible for managing activities related to product safety surveillance and risk management, including review of data from clinical studies and spontaneous complaints for accuracy, completeness, regulatory reporting, and potential safety issues. As a liaison between...
-
SMTE- Active Safety Specialist
1 week ago
Pune, Maharashtra, India Tata Motors Full timeJob DescriptionWe are seeking a highly skilled Active Safety System Engineer to join our team at Tata Motors. The ideal candidate will have a strong background in software development and implementation, with a focus on active safety systems.Key ResponsibilitiesDevelop and implement active safety system softwareDesign and implement ABS and ESP...
-
EHS Specialist
2 weeks ago
Pune, Maharashtra, India Synventive Molding Solutions JBJ Ltd. Full timeJob Title: EHS SpecialistAt Synventive Molding Solutions JBJ Ltd., we are seeking a highly skilled EHS Specialist to join our team. The successful candidate will be responsible for ensuring the health and safety of our employees, contractors, and visitors, as well as maintaining compliance with relevant laws and regulations.Key Responsibilities:Coordinate...