ICSRs Project Lead - Hyderabad / Secunderabad, Telangana - Thepharmadaily

    Thepharmadaily
    Thepharmadaily Hyderabad / Secunderabad, Telangana

    1 day ago

    Full time
    Description
    • Project Leadership: Serve as the ICSRs Project Lead for post-marketing pharmacovigilance projects, adhering to client contracts and applicable Standard Operating Procedures (SOPs) and Work Instructions (WIs).
    • Adverse Event Management: Oversee the receipt and processing of all adverse event reports from various sources, including spontaneous reports and clinical trials, for assigned projects.
    • Database Management: Maintain a thorough understanding of client-specific database conventions and support reconciliation with internal or external partners as needed.
    • Workflow Monitoring: Support workflow monitoring to ensure project deadlines are met.
    • Safety Presentations: Draft, modify, and deliver safety presentations to both external and internal stakeholders.
    • SOP and WI Development: Assist in creating and updating departmental Work Instructions (WIs) and Standard Operating Procedures (SOPs).
    • Regulatory Compliance: Ensure compliance with ICSR regulatory submission requirements according to US and international regulations, SOPs, and safety processing guidelines.
    • Scheduling Reports: Manage automated and manual scheduling of regulatory reports in the safety database, including initial, follow-up, amendment, nullification, and downgrade reports.
    • Case Processing: Handle case processing in Argus, including solicited, literature, and spontaneous cases.
    • Reporting: Generate monthly status and project-specific reports, ensuring the quality and accuracy of metrics and data.
    • Quality Checks: Perform quality checks on case data and finalize case versions.
    • Follow-Up and Amendments: Conduct case follow-ups, generate queries and clarifications, and perform case amendments or deletions as needed.
    • Investigation and CAPAs: Conduct late case investigations, propose corrective and preventive actions (CAPAs), and support process/training remediation.
    • Data Clean-Up: Support reconciliation, replenishment, and data clean-up activities.
    • Safety Database Updates: Assist with safety database updates and data migration activities.
    • Process Improvement: Investigate and address process or training issues, facilitating the creation of CAPAs and supporting remediation efforts.
    • Client and Team Liaison: Actively participate in project team and client meetings, liaise with clients as appropriate, and prepare for internal, client, or regulatory audits.

    Education and Experience:

    • Master s Degree in Pharmacy (M.Pharm) or Doctor of Pharmacy (Pharm D).
    • Minimum of 10 years of experience in pharmacovigilance and safety.

  • Work in company

    IT Project Lead

    Medtronic

    As an IT Project Lead - Project Manager at Medtronic, you will be responsible for leading and directing multiple IT projects within the Enterprise Architecture Data Platforms (EADP) organization. This includes managing projects related to large-scale application development, syst ...

    Hyderabad / Secunderabad, Telangana ₹1,200,000 - ₹2,800,000 (INR) per year Full time

    1 day ago

  • Work in company

    Project Lead

    confidential

    Luxoft DXC Technology Company is an established company focusing on consulting and implementation of complex projects in the financial industry. At the interface been technology and business, we convince with our know-how, well-founded methodology and pleasure in success. As a re ...

    Hyderabad / Secunderabad, Telangana ₹900,000 - ₹2,200,000 (INR) per year Full time

    5 days ago

  • Work in company

    IT Project Lead

    Medtronic

    A Day in the Life The project lead works independently with general supervision on larger, complex project, program and portfolio (PPP) assignments. The IT Project Lead takes full responsibility for the successful implementation of the outcomes derived through the change via effe ...

    Hyderabad / Secunderabad, Telangana ₹1,200,000 - ₹2,800,000 (INR) per year Full time

    1 day ago

  • Work in company

    QA Project lead

    Adecco India Private Limited

    An Ideal Candidate: · Have Experience · • 5+ years of experience in Quality Assurance including 1 or more years in leading a project. · • 1+ years of experience in people management. · • Experience with project management and bug tracking tools (e.g. Jira) in an agile environment ...

    Hyderabad / Secunderabad, Telangana Full time

    1 day ago

  • Work in company

    It Project Manager Lead

    confidential

    Lead and manage data-driven projects from initiation to completion, ensuring timely delivery and alignment with business objectives. · Experienced in at least in one of the following engagements - BI/DW, DWH, Data Warehousing, Data Analytics, Business Intelligence, Data Projects, ...

    Hyderabad / Secunderabad, Telangana ₹1,800,000 - ₹3,800,000 (INR) per year Full time

    5 days ago

  • Work in company

    ICSRs Project Lead

    Thepharmadaily

    Key Responsibilities: · Perform as the ICSRs Project Lead for assigned pharmacovigilance projects. · Oversee the receipt and processing of all adverse event reports, whether from spontaneous sources or clinical trials. · Maintain knowledge of client-specific database conventions. ...

    Hyderabad / Secunderabad, Telangana Full time

    1 day ago

  • Work in company

    Civil Projects Lead

    confidential

    Key Responsibilities: · Manage a team of civil engineers and provide daily updates to the central projects team · Coordinate with cross-functional business teams for timely execution of civil works for new store openings · Validate site measurements, layouts, and review technical ...

    Hyderabad / Secunderabad, Telangana Full time

    5 days ago

  • Work in company

    Civil Projects Lead

    confidential

    Key Responsibilities: · Manage the civil project team and provide daily updates to the central team · Coordinate with internal business units and cross-functional teams to execute store civil works · Validate site measurements, layouts, and technical drawings · Review and approve ...

    Hyderabad / Secunderabad, Telangana Full time

    5 days ago

  • Work in company

    Lead Safety – Projects

    Adani Group

    1. PURPOSE OF THE ROLE: · 1. Conduct regular site inspections to identify potential hazards and ensure compliance with HSE regulations and company policies. · 2. Scrutinizing the Incident Investigations, near misses, Dangerous occurrences of the contractors/ vendors and advising ...

    Hyderabad / Secunderabad, Telangana Full time

    1 day ago

  • Work in company

    Assistant project lead

    Jones Lang Lasalle Property Consultants

    Key Responsibilities · Plan all the works and monitor the same. Identify the risk and propose mitigation. Co-ordinate with internal and external stakeholders. · Coordination with Design Consultants for ensure deliverables of all Fire Protection and Alarm services and co-ordinatio ...

    Hyderabad / Secunderabad, Telangana ₹600,000 - ₹1,800,000 (INR) per year Full time

    1 day ago

  • Work in company

    Business Project Lead Analyst

    Cigna Medical Group

    The Business Project Analyst partners with the CIM PMO and workstream owner structure. Key stakeholder partners will be Finance, Accounting, Technical Teams and Automation and AI teams. · Collaborate with Workstream Lead to support requirements identification, documentation and c ...

    Hyderabad / Secunderabad, Telangana ₹800,000 - ₹2,000,000 (INR) per year Full time

    1 day ago

  • Work in company

    Strategy Project Management Lead

    confidential

    We are seeking an experienced and dynamic Strategy Project Management Lead to take ownership of assigned projects, ensuring their successful and timely completion. The role requires strong leadership in project planning, execution, and risk management to meet strategic business o ...

    Hyderabad / Secunderabad, Telangana Full time

    5 days ago

  • Work in company

    Integrated Project Team Lead

    Cyient Inc

    Leads Class 1 and Class 2 engineering change execution. · Identifies and addresses project problems and recommends resolutions to ensure the successful completion of projects. · Facilitates project tasks with the various functional organizations to ensure alignment with overall p ...

    Hyderabad / Secunderabad, Telangana Full time

    1 day ago

  • Work in company

    Project Manager/ Lead MEP

    Jones Lang Lasalle Property Consultants

    Roles and Responsibilities: · Coordinate with internal stakeholders, proactively review the design and highlight any issues within external stakeholders. · Plan the daily/ weekly/ monthly progress track the same. · Identify the risk and propose mitigations. · Coordination with D ...

    Hyderabad / Secunderabad, Telangana Full time

    1 day ago

  • Work in company

    HIH - IT Project Management Lead Analyst - Evernorth

    Cigna Medical Group

    Key Responsibilities · Analyze data from multiple sources across enterprise toolsets to design and develop repeatable views and extracts. · Design, develop, and deploy visual dashboards or reports that simplify and streamline data consumption using Excel and Tableau. · Use SQL to ...

    Hyderabad / Secunderabad, Telangana Full time

    1 day ago

  • As a Senior IT Project Lead for Global Operations & Supply Chain (GOSC) Manufacturing Systems Digitalization at Medtronic, you'll spearhead the implementation of critical IT systems to drive digital transformation across our manufacturing operations. You'll be responsible for end ...

    Hyderabad / Secunderabad, Telangana Full time

    1 day ago

  • Work in company

    Big data Lead

    confidential

    Role- Big data Lead · Job Description · Desired Competencies (Technical/Behavioral Competency) · Big data · Spark · Scala · Project Management · Responsibilities · Good experience in MQ or kafka or Rabbit MQ · Exp in .Terraform, Kubernete · CI/CD, Cloud · Good stakeholder managem ...

    Hyderabad / Secunderabad, Telangana ₹1,200,000 - ₹2,400,000 (INR) per year Full time

    5 days ago

  • Work in company

    Project Manager

    Apollo Telehealth

    We are seeking an experienced Project Manager to join our team in India. The ideal candidate will have a strong background in project management with proven experience in leading projects from conception to completion. · Responsibilities · Lead and manage multiple projects from i ...

    Hyderabad / Secunderabad, Telangana ₹600,000 - ₹1,500,000 (INR) per year Full time

    1 day ago

  • Work in company

    Senior Delivery Manager

    confidential

    Essential Duties and Responsibilities : · Lead one or multiple projects at one go · Lead Medium and Large project while working with Vendor and customers · Lead the project manager internally and externally · Independently take up and lead Business Blueprint workshops, Design End ...

    Hyderabad / Secunderabad, Telangana Full time

    5 days ago

  • Work in company

    IT delivery manager

    confidential

    Blueberry Digital Labs is seeking a skilled and results-driven IT Delivery Manager to oversee the successful execution of our projects. In this pivotal role, you'll be responsible for managing projects from start to finish, ensuring they are delivered on time, within budget, and ...

    Hyderabad / Secunderabad, Telangana Full time

    5 days ago

Jobs