Spec I Pss

7 days ago


Navi Mumbai, India Labcorp Full time

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 Labcorp’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

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp 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.


  • Spec I Pss

    2 weeks ago


    Navi Mumbai, India Labcorp Full time

    Bachelors - Life sciences 2-4 Years Efficiency in conducting literature searches for authoring various types of reports  Write various safety reports (or part of such reports) for global regulatory submissions for Labcorp’s clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports,...

  • Spec I Pss

    1 day ago


    Navi Mumbai, India Labcorp Full time

    Labcorp Drug Development As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired...

  • Asst I Pss

    7 days ago


    Navi Mumbai, India Labcorp Full time

    Labcorp Drug Development As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired...

  • Spec I Pss

    2 weeks ago


    Mumbai, India Fortrea - Organic Full time

    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...


  • Navi Mumbai, Maharashtra, India Fortrea Full time

    **Job Overview**: Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to...


  • Navi Mumbai, Maharashtra, India beBeeOperational Full time ₹ 8,00,000 - ₹ 20,00,000

    Job OverviewWe are seeking an exceptional Operations Manager to lead our team of mechanical engineers and contribute towards achieving company objectives.Main Responsibilities:Understand customer orders and oversee timely preparation and accurate technical specs.Ensure mechanical designs are submitted with minimal iterations.Respond to non-conformities such...


  • Navi Mumbai, Mumbai City, Mumbai, India beBeeExpert Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

    Job Title: JD Edwards Finance System ExpertThe ideal candidate will possess in-depth knowledge of JD Edwards finance modules, including AR, AP, GL, and FA. They will be responsible for leading the finance team, conducting meetings, and facilitating large group sessions with stakeholders.Key Responsibilities:">Lead the integration testing effort, developing...


  • Mumbai, Maharashtra, India YOU & I Consulting Full time ₹ 3,00,000 - ₹ 6,00,000 per year

    Job description*You & I Consulting has always been in the spotlight for getting placed in 64+ MNC's PAN India.*We At You & I Consulting, Embracing the power of diversity, our organization is committed tofostering an inclusive work environment by focusing on women hiring for our remote serviceassociate roles.*Work from home with Virtual Customer ServiceRole:...


  • Mumbai, Maharashtra, India Halliburton Full time

    We 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...


  • Mumbai, Maharashtra, India NCR Atleos Full time

    About NCR NCR Corporation (NYSE: NCR) is a leader in transforming, connecting and running technology platforms for self-directed banking, stores and restaurants. NCR is headquartered in Atlanta, Ga., with 38,000 employees globally. NCR is a trademark of NCR Corporation in the United States and other countries. - Position Description - The Remote Resolution...