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6.0 years
5 - 10 Lacs
Hyderabad
Work from Office
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Title: Safety Data Exchange Agreement (SDEA) Drug Safety Specialist Job Summary: The SDEA Pharmacovigilance (PV) Specialist is responsible for managing Safety Data Exchange Agreements between the company and its partners in the contract management database, ensuring compliance with global pharmacovigilance regulations and facilitating efficient exchange of safety information, coordinating with various stakeholders, manage the lifecycle of SDEAs/PVAs for business relationships ensuring to meet the standard process and applicable regulatory requirements. Responsible to assess contractual information related to PV obligations on different type of reports like individual case safety reports, aggregate reports, signal reports, literature screening and other PV related aspects. Key Responsibilities : Management of Global and Local SDEAs (SDEA / PV clause / Pharmacovigilance Agreement / Vigilance Agreement, PV Agreement for Clinical Supply, Divestments) for investigational, post marketing, marketed products, vaccines and medical devices. Review and assessment of PV obligations from contracts on different type of reports ICSR processing and timelines, PSURs/PBRERs, RMPs, Signal detection, Clinical study reports, periodic line listings, literature screening, labeling etc. to ensure accurate information is entered in the database. Management of Safety database related configuration requests and updates. Build and manage reports (Business Partner lists) periodically from the Contract management database to provide the operational functions with the latest contacts list for implementation in their processes or systems Maintain a database of all agreements and track their status, expiration dates, and amendments. Provide guidance on SDEA-related issues to stakeholders and non-stakeholders. Ensure timely execution of SDEAs in the database to support project timelines. Strict adherence to the standard operating procedures (SOPs) and guidelines. Ensure all executed PVAs and its Main agreements are tracked within Global Comprehensive tracker and filed within dedicated share folder. Provide support in ad-hoc activities to support the periodic aggregate teams for preparation of PSURs/DSURs Efficient in mailbox management and reconciliations. Conduct training sessions on SDEA processes and requirements for relevant staff. Perform Quality check on the processed data entries. Monitoring of Key performance indicators (KPIs) and metrics. Stay current with global pharmacovigilance regulations and industry best practices. Participate in audits and inspections related to safety data exchange processes. Qualifications: Bachelor's degree in Life Sciences, Pharmacy, or a related field. Advanced degree preferred. 2-3 years of experience in pharmacovigilance, clinical research, or a related field. Knowledge and Experience : Related experience in drug safety/ pharmacovigilance and contract (SDEA/PVA) management is desirable Strong knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH, EMA, FDA). Strong knowledge of pharmacovigilance terminologies on Individual case safety reports, Aggregate safety reports, Signal and risk management, and related regulations and guidelines (e.g., ICH, EMA, FDA). Strong knowledge about the master service agreements and terminologies. Experience in management of the ICSRs in safety database. Understanding of medical terminology and adverse event coding. Experience in automation / artificial intelligence would be an asset. Desired Skills: Sound knowledge of drug safety, data analysis and evaluation of safety data Ability to work collaboratively and effectively in a team environment Client focused approach to work Ability to evaluate data and draw conclusions independently Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Computer proficiency, IT skills, the expertise and ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point)
Posted 1 day ago
5.0 - 10.0 years
5 - 15 Lacs
Mumbai
Work from Office
SUMMARY SAR & SAR-like Patient Safety Physician Job Description Responsible for compiling PBRERs with a focus on medical aspects and safety sections of products, and analyzing safety trends, including source data analysis based on queries Assisting in identifying, analyzing, and drawing conclusions from safety data for cumulative trends Collaborating with Therapeutic Head to identify signals and address product safety concerns Engaging with Therapeutic Area colleagues for enhanced understanding and development Measurable Goals Ensuring 100% compliance with timely completion of all client and Cognizant required trainings Achieving 100% compliance with work allocation plan, including case closure based on agreed timelines and quality benchmarks Non - Measurable Attributes Self - motivated Goal-oriented Interdepartmental collaboration Personal grooming and etiquette Punctuality Team player and process-oriented Competencies Proficient in delivering presentations Effective at collaborating across different cultures Strong preference for structured and process-driven tasks Committed to completing training and documentation on time Experience Relevant educational background and experience in patient safety or related field Required Skills Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities Requirements Requirements: Relevant educational background and experience in patient safety or related field Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities
Posted 5 days ago
8.0 - 12.0 years
18 - 20 Lacs
Pune
Work from Office
Description Job Purpose: Introduction of Asian Paints Admixtures in tendering process through Government, Semi Government & Private organizations Business Responsibility Areas: 1 Strategic Execution • Making specific Govt sub segment plan basis on the potential of these sub segments and strategies to deliver them • Building relationships with the top decision makers in the Govt/Infra/CCC companies/ RMC/ Builder Segment • Working closely with the Internal specification team to ensure delivery of the Specification plans for Admixtures Develop sales growth of Admixture segment and prepare strategy for expansion • Introduction of products in tendering process through Government, Semi Government & Private organizations • Analysis of Tendering process with competitors study with respect to price, packing, formulations etc • Preparation & Filing of Tender documents • Generating repeat sales once Rate Contract is Sanctioned Handling complete business cycle of sales though Tendering process • Development of sales through different institutional channel such with respected authorities for successful bidding process 2 Support Annual business planning 3 Customer Satisfaction Management: Assessment of Customer satisfaction and assess new collaboration for value addition Closely work with: 1 Internal : a Specifications Team b Govt Teams c Admix sales and technical teams d Marketing & Technology teams 2 External : a Civil Construction Companies End Customers for Govt/Infra projects b Channel Partners like Distributors/ Consultants/ RMC/ Builders Quality Team Education: BE/BTech - Civil/Chemical Work Experience: Candidates having more than 8 years of experience in Admixtures/Construction Chemicals segment
Posted 6 days ago
5.0 - 10.0 years
5 - 15 Lacs
Mumbai
Work from Office
SUMMARY SAR & SAR-like Patient Safety Physician Job Description Responsible for compiling PBRERs with a focus on medical aspects and safety sections of products, and analyzing safety trends, including source data analysis based on queries Assisting in identifying, analyzing, and drawing conclusions from safety data for cumulative trends Collaborating with Therapeutic Head to identify signals and address product safety concerns Engaging with Therapeutic Area colleagues for enhanced understanding and development Measurable Goals Ensuring 100% compliance with timely completion of all client and Cognizant required trainings Achieving 100% compliance with work allocation plan, including case closure based on agreed timelines and quality benchmarks Non - Measurable Attributes Self - motivated Goal-oriented Interdepartmental collaboration Personal grooming and etiquette Punctuality Team player and process-oriented Competencies Proficient in delivering presentations Effective at collaborating across different cultures Strong preference for structured and process-driven tasks Committed to completing training and documentation on time Experience Relevant educational background and experience in patient safety or related field Required Skills Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities Requirements Requirements: Relevant educational background and experience in patient safety or related field Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities
Posted 1 week ago
3.0 - 8.0 years
3 - 4 Lacs
Mumbai, Mumbai Suburban
Work from Office
Reinforcement checking as per B.B.S & drawing Monthly Concrete reconciliation Checking the quality of concrete at pumping station before pumping. DP Test , Formwork checking, Maintain of all document as per QAP CTC upto 5LPA Whatsapp on 9820831597 Required Candidate profile B.E./ B.Tech in Civil Must have 3+ years Exp in High Rise Building Prefer candidate working in civil contracting firm
Posted 2 weeks ago
6.0 - 11.0 years
10 - 15 Lacs
Pune, Mumbai (All Areas)
Work from Office
Hi We are Hiring for ITES Company for the Pharmacovigilance Aggregate Reporting Role Job Description: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.) To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. Drafting and maintaining PV agreements and SDEA'S Workflow management along with case allocation Accountable for updating relevant databases, repositories, trackers and logs on an ongoing basis as per relevant SOPs Submission of cases to various regulatory Authorities (EMA, MHRA, FDA, Health Canada) Execute drug safety data management process- a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation- with accountability for quality and timelines of deliverables and responsibility for process improvements Maintaining and drafting project level SOPs as per Statement of Work. Create/collate periodic reports for client report meetings. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 54 b) To Apply for above Job Role ( Pune ) Type : Job Code # 55
Posted 2 weeks ago
6.0 - 10.0 years
10 - 15 Lacs
Pune, Mumbai (All Areas)
Work from Office
Hi, We are hiring for Leading ITES Company for Aggregate Report Writer Profile. Please Apply, We shall call back relevant profiles. Role & responsibilities: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.). To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 54 b) To Apply for above Job Role ( Pune ) Type : Job Code # 55
Posted 2 weeks ago
5.0 - 10.0 years
5 - 15 Lacs
Mumbai
Work from Office
SUMMARY SAR & SAR-like Patient Safety Physician Job Description Responsible for compiling PBRERs with a focus on medical aspects and safety sections of products, and analyzing safety trends, including source data analysis based on queries Assisting in identifying, analyzing, and drawing conclusions from safety data for cumulative trends Collaborating with Therapeutic Head to identify signals and address product safety concerns Engaging with Therapeutic Area colleagues for enhanced understanding and development Measurable Goals Ensuring 100% compliance with timely completion of all client and Cognizant required trainings Achieving 100% compliance with work allocation plan, including case closure based on agreed timelines and quality benchmarks Non - Measurable Attributes Self - motivated Goal-oriented Interdepartmental collaboration Personal grooming and etiquette Punctuality Team player and process-oriented Competencies Proficient in delivering presentations Effective at collaborating across different cultures Strong preference for structured and process-driven tasks Committed to completing training and documentation on time Experience Relevant educational background and experience in patient safety or related field Required Skills Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities Requirements Requirements: Relevant educational background and experience in patient safety or related field Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities
Posted 2 weeks ago
10 - 20 years
1 - 4 Lacs
Chennai
Work from Office
Job Summary : We are seeking an experienced and technically proficient Lab Manager to lead and oversee all operations of our construction materials testing laboratory. The Lab Manager will be responsible for managing staff, ensuring testing accuracy, maintaining equipment and standards, and ensuring compliance with industry regulations. The ideal candidate will have a strong background in civil/materials engineering and proven experience in a construction materials testing environment. Key Responsibilities Oversee daily lab activities including material testing (e.g., concrete, cement, soil, aggregates, steel, asphalt). Ensure all testing is conducted as per national and international standards (e.g., IS, ASTM, BS). Maintain proper documentation, test records, and calibration logs. Ensure lab accreditation and compliance with regulatory requirements (e.g., NABL, ISO/IEC 17025). Review and approve test reports before submission to clients. Supervise lab technicians, assistants, and field testing staff. Provide training and guidance on testing procedures, safety, and equipment handling. Schedule workload to ensure timely completion of testing activities. Prepare and present technical reports, audit documentation, and internal performance reviews Maintain test data, reports, and correspondence for future reference and compliance. Ensure proper maintenance, calibration, and operation of all lab equipment. Ensure timely delivery of accurate and clear test results. Schedule workload to ensure timely completion of testing activities. Provide training and guidance on testing procedures, safety, and equipment handling.
Posted 1 month ago
- 1 years
3 - 4 Lacs
Noida
Work from Office
Key Responsibilities: Identify and aggregate YouTube videos based on business and platform content needs. Conduct quality audits of video content for relevance, production standards, and platform alignment. Evaluate content using predefined quality benchmarks such as view duration, engagement rate, metadata accuracy, and visual/audio quality. Flag and recommend removal of low-performing or non-compliant videos. Key Requirements: Bachelor's degree in media, Mass Communication, English Working knowledge of MS Excel/Google Sheets Familiarity with AI tools (e.g., ChatGPT) to assist with content summarization and classification. Strong eye for content accuracy, quality, and compliance. Ability to apply standardized QA checklists Good written and verbal communication skills. Self-motivated with a strong sense of ownership and accountability.
Posted 1 month ago
6 - 10 years
10 - 15 Lacs
Pune, Mumbai (All Areas)
Work from Office
Hi, We are hiring for Leading ITES Company for Aggregate Report Writer Profile. Please Apply, We shall call back relevant profiles. Role & responsibilities: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.). To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)
Posted 1 month ago
6 - 11 years
10 - 15 Lacs
Pune, Mumbai (All Areas)
Work from Office
Hi We are Hiring for ITES Company for the Pharmacovigilance Aggregate Reporting Role Job Description: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.) To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. Drafting and maintaining PV agreements and SDEA'S Workflow management along with case allocation Accountable for updating relevant databases, repositories, trackers and logs on an ongoing basis as per relevant SOPs Submission of cases to various regulatory Authorities (EMA, MHRA, FDA, Health Canada) Execute drug safety data management process- a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation- with accountability for quality and timelines of deliverables and responsibility for process improvements Maintaining and drafting project level SOPs as per Statement of Work. Create/collate periodic reports for client report meetings. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)
Posted 1 month ago
12 - 15 years
7 - 14 Lacs
Hyderabad
Work from Office
Assistant Manager/Deputy Manager - Procurement Job description Role & responsibilities 1. Having good knowledge on finalisation of Electrical Contract Packages 2. Thorough knowledge in Preparing of Cost Analysis, Estimations, Tendering process, Comparative statements & Approval notes. 3. Having Very Good functional Knowledge in understanding of Electrical Packages BOQ with detailed scope of works like Contractor scope & Company Scope. 4. Good in finalisation of Contracts like packages related to Internal Electrical, External Electrical, Landscape Electrical, Earthing Works, DG Exhaust Piping, Lighting Protection works Etc... 5. Having Good Exposure and Knowledge in finalisation of Vendors for Residential, Commercial buildings & Malls Electrical packages. 6. Required Good Drafting & communication, interpersonal & Negotiation skills 7. Having best experience in Procurement cycle (i.e. PR to PO & Procurement to Pay ) to handle all the Electrical Commodity Components/ aggregates /Products /Units like LT & HT Panels, Cables, Bus duct, Light Fittings, DG sets, Cable tray's, Conduits, Copper Wires, Earthing items & allied items . 8. Preparation of Rate Analysis, Comparative Statements & final proposals to Management. 9. Co-ordination with cross functional Teams/departments for BOQ queries & Specification technical queries. 10. Arranging technical Discussions with Internal & external stake holders 11. Ensuring that all the changes to the scope due to any reason (site conditions etc.) are recorded and amendments are made for approval 12. Evaluating the performance of the vendor at regular intervals & documenting the same 13. Performing techno commercial evaluation of rates quoted by contractors 14. Closely examining the contracts PO and agreement of all projects. 15. Preparing Savings reports Note: Looking for High Rise Building Construction Experience only Role: Deputy Manager/Manager - Procurement Industry Type: Engineering & Construction Department: Procurement Employment Type: Full Time, Permanent Role Category: Other Education UG: B.Tech/B.E. in Electrical Kindly Share Your CV to : prabhakar-hr@aparnaconstructions.com
Posted 1 month ago
3 - 7 years
7 - 13 Lacs
Ballabhgarh, Faridabad, Manesar
Work from Office
Role & responsibilities E&E Control system design, development, and Integration. Profound knowledge in design and development of system architecture and control system. 1. Profound knowledge in logic and algorithm development for defined control system. 2. Knowledge in writing the functional requirement specification for machine control system and their test cases. 3. Conducting V&V testing, generating report and root cause analysis of failures. 4. Understanding of various ECU and its use in machine control. 5. Software development experience on MATLAB or some other prototype development software like IQANdesign, Plus+1, Bodas Design. 6. Work experience on software optimization, testing and validation on bench and machine. 7. Work experience on machine fault identification, handling and issue resolution. Interested one`s revert me swati.shikha@mounttalent.com
Posted 1 month ago
6 - 10 years
10 - 15 Lacs
Pune, Mumbai (All Areas)
Work from Office
Hi, We are hiring for Leading ITES Company for Aggregate Report Writer Profile. Please Apply, We shall call back relevant profiles. Role & responsibilities: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.). To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)
Posted 1 month ago
6 - 11 years
10 - 15 Lacs
Pune, Mumbai (All Areas)
Work from Office
Hi We are Hiring for ITES Company for the Pharmacovigilance Aggregate Reporting Role Job Description: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.) To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. Drafting and maintaining PV agreements and SDEA'S Workflow management along with case allocation Accountable for updating relevant databases, repositories, trackers and logs on an ongoing basis as per relevant SOPs Submission of cases to various regulatory Authorities (EMA, MHRA, FDA, Health Canada) Execute drug safety data management process- a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation- with accountability for quality and timelines of deliverables and responsibility for process improvements Maintaining and drafting project level SOPs as per Statement of Work. Create/collate periodic reports for client report meetings. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)
Posted 1 month ago
1 - 5 years
3 - 5 Lacs
Kolkata
Work from Office
1. Placement of SXL/MXL trucks across PAN India. 2. Onboard reliable truckers and ensure timely and safe delivery of materials. 3. Monitor Proof of Delivery (POD) collection and maintain delivery TAT. Required Candidate profile Minimum 1 year of experience in the freight aggregation industry, specifically with container vehicles. Proven ability to place vehicles from Kolkata to locations across India.
Posted 1 month ago
2 - 6 years
4 - 9 Lacs
Gurgaon
Remote
Role & responsibilities :- Candidate is primarily responsible for but not limited to: 1) ADR case triage and validity assessment: Perform triage of ADR cases for seriousness/follow up significance and identification of suspect products and events. Perform ADR case validity assessment. 2) Adverse Drug Reaction (ADR) processing Perform medical review of ICSRs Review of Literature Alerts and Medical Information Perform event listedness assessment to enable expedited reporting of ICSRs as per applicable regulatory requirements 3) Periodic Safety Report generation Medical Review of Periodic safety reports Medical review of line listings, query response, case correction. 4) Risk management Plan Preparation of Risk Management Plan 5) Other Pharmacovigilance projects Work in any other assigned Pharmacovigilance project Ensure compliance to applicable SOPs Maintenance of personal Pharmacovigilance record as per the applicable SOP Skills : Good Communication Skills, Awareness of global drug safety guidelines, sound medical knowledge, workflow management
Posted 2 months ago
6 - 11 years
10 - 15 Lacs
Pune, Mumbai (All Areas)
Work from Office
Hi We are Hiring for ITES Company for the Pharmacovigilance Aggregate Reporting Role Job Description: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.) To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. Drafting and maintaining PV agreements and SDEA'S Workflow management along with case allocation Accountable for updating relevant databases, repositories, trackers and logs on an ongoing basis as per relevant SOPs Submission of cases to various regulatory Authorities (EMA, MHRA, FDA, Health Canada) Execute drug safety data management process- a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation- with accountability for quality and timelines of deliverables and responsibility for process improvements Maintaining and drafting project level SOPs as per Statement of Work. Create/collate periodic reports for client report meetings. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)
Posted 2 months ago
6 - 11 years
5 - 8 Lacs
Sonipat/Sonepat, Delhi NCR, Gurgaon
Work from Office
Role: Quality Control Engineer Exp 507 Years Budget INR 5-7.5 L Job Location: Gurugram or Kundali -Sonipat Role Objective: Shall have sound understand of Drawings and Activities sequencing for quality Delivery of project. He should have involved in the Complete cycle of Project Construction Quality from the start to handing-over a Five Star Hotels Project from Developer side independently . Shall be fully aware of what the quality procedures are for all aspects of the works. Job Role and Key Deliverable: 1. To set up QA and QC Procedures for Construction good, items and work method statements at project /site 2. Oversee compliance of SOPs by contractors and suppliers 3. Preparation of Quality Formats/Checklists for all construction activities of Civil (Structural & Finishing) and all related MEP works . 4. Coordination with contractors and site staff to maintain the checks of quality for all works in progress at site and maintaining the records of the same. 5. Raising and closing of Noncompliance Reports-NCR's for all the agencies working at site. 6. Promotes and improves Quality, through accuracy and thoroughness. 7. Draft and implement Field Quality Plan and ensure implementation 8. Oversee QC tests and records of QC engineers of contractors 9. Coordinate with external consultants and obtain advice for Materials and Workmanship 10. Coordinate between RMC plant and site concreting Preferred candidate profile: Dip/ Degree with 6-10 years of QC experience in RCC/ Finishing works Must be aware of tests of Cement related works as well as Structural steel related works Should have knowledge of RCC design mix and concrete batching plant Should have sound knowledge of materials in construction Pls share the following details ASAP: a. Updated CV b. Current & Exp CTC c. Notice Period d. Total Exp in QA-QC in Construction Engineering: e. Availability for an interview in Gurgaon- Pls Share Date / Time Perks and benefits: As per Industry best Practices and commensurate with domain expertise and experience
Posted 2 months ago
5 - 6 years
0 - 5 Lacs
Hyderabad
Work from Office
YASHODA MULTISPECIALITY HOSPITAL IS HIRING FOR ASSISTANT MANAGER ROLE - HYDERABAD - APPLY NOW!!! Roles and Responsibilities : Manage material procurement for civil construction projects, ensuring timely delivery of high-quality materials. Coordinate with suppliers to negotiate prices, resolve issues, and improve relationships. Plan and execute purchasing strategies to meet project requirements while minimizing costs. Ensure compliance with company policies, industry standards, and regulatory requirements. Job Requirements : 5-6 years of experience in building construction or related field (civil engineering). Strong knowledge of cement, aggregate, steel, shuttering materials used in civil construction. Proven track record in material procurement for large-scale building projects.
Posted 2 months ago
4 - 8 years
3 - 5 Lacs
Gurgaon
Work from Office
Perform quality control inspections on construction materials and processes, ensure compliance with standards, conduct tests, report defects, and assist in maintaining high-quality project execution.
Posted 2 months ago
6 - 10 years
8 - 15 Lacs
Pune, Mumbai (All Areas)
Work from Office
Hi, We are hiring for Leading ITES Company for Aggregate Report Writer Profile. Please Apply, We shall call back relevant profiles. Role & responsibilities: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.). To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)
Posted 2 months ago
6 - 11 years
15 - 20 Lacs
Pune, Mumbai (All Areas)
Work from Office
Hi We are Hiring for ITES Company for the Pharmacovigilence Aggregate Reporting Role Job Location - Pune / Mumbai Job Description: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.) To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. Drafting and maintaining PV agreements and SDEA'S Workflow management along with case allocation Accountable for updating relevant databases, repositories, trackers and logs on an ongoing basis as per relevant SOPs Submission of cases to various regulatory Authorities (EMA, MHRA, FDA, Health Canada) Execute drug safety data management process- a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation- with accountability for quality and timelines of deliverables and responsibility for process improvements Maintaining and drafting project level SOPs as per Statement of Work. Create/collate periodic reports for client report meetings. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)
Posted 2 months ago
3 - 8 years
8 - 18 Lacs
Navi Mumbai, Mumbai
Work from Office
Expertise in end to end implementation ELK Stack covering Elasticsearch, Logstash, and Kibana. Conceptual good understanding about Elastic search cluster ,Shards and replica Conceptual good understanding about Elastic search configuration, API and local gateway. In depth analysis of mapping ,Indexing and operations In depth understanding of transactions logs and Lucene Indexing. In depth understanding of multiple indices, index aliases and cross-index operations. In depths understanding configurations options, ,mappings and APIs and available settings Understanding of Search query DSL In depth understanding of search components, aggregations, search types,, highlighting and other options. In depth knowledge of filebeat, bitSets and Lucene In depth understanding of aggregations and nested document relations. In depth understanding of cluster state recovery, low level replication , low level recovery and shared allocation. In depth understanding of performance tuning, more on data flow and memory allocation. Good understanding in Kibana and cluster monitoring Good understanding in Hadoop Environment and its eco system and infrastructure. Expertise in Tuning and troubleshooting of Elastic search and its stack Excellent knowledge in O/S and networks. Expertise in security of the Elastic search and its stack. Upgrade elastic search version and its stack like kibana ,logstash. Diligently teaming with the infrastructure, network, database, application and business intelligence teams to guarantee high data quality and availability. Excellent troubleshooting skill for elastics search.
Posted 2 months ago
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