ICSRs Project Lead - Pharmacovigilance Thepharmadaily

10.0 - 12.0 years

8 - 13 Lacs

Hyderabad, Telangana, India

On-site

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.

Posted 2 days ago

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Lease Administrator Colliers

4.0 - 9.0 years

4 - 9 Lacs

Chennai

Work from Office

Role & responsibilities Abstract and Review the Lease documents or any Amendments. Manage and update all leases in the Lease Admin system. To communicate with clients on a regular basis. Assist in new account transition and setup as required. Able to complete the assigned tasks and activities within deadline. Responsible for maintenance of account process, procedures and playbooks and update as needed. Coordinate information among departments. Provide strong feedback for all tasks performed by Lease Analyst and train all dependencies on best practices. Manage daily/weekly progress reporting and defect tracking. Escalates issues and risks to project leader in accordance with best practices. Must have strong technical aptitude and analytic background needed to understand applications and data infrastructure Excellent verbal communication and email drafting skills. Expertise in MS-Office packages (basic excel knowledge mandatory) Preferred candidate profile The successful candidate will possess the following required degrees, certificates, or competencies: Bachelors degree in business, accounting, real estate, or similar field preferred. Working experience with commercial real estate database applications such as WorkTrac, ProLease, HF/APEX, Lucernex, CoStar, Tango, Big Center, Visual Lease and accounting software such as MRI or Yardi or other lease management systems. Qualified candidates should have at least 3 years of relevant experience in the commercial real estate lease administration industry.

Posted 1 month ago

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Urgent opportunity into labour compliance - Licenses & Registration Core Integra Consulting Services

2.0 - 7.0 years

1 - 3 Lacs

Pune, Bengaluru, Mumbai (All Areas)

Work from Office

Hello, Greetings from Core Integra Consulting Services Ltd!! Company Profile: - We are into End to End HR Solution, with expertise in HR Compliance, Temp Staffing & Talent Acquisition For more details kindly go through Company website: www.coreintegra.com. Currently we have an opening for Executive / Sr. Executive - Compliance Location - Bangalore (Koramangala) , Mumbai (Andheri East - MIDC walkable from JB nagar Chakala Metro station), Pune Candidates should be aware of S&E registration S&E RC, CLRA registration, CLRA RC, Factory registration, Licenses, Trade licenses, various license & registration for pan India Initiating and Completing the Registration / Renewals /Amendments / Surrendering of License / RC under S&E, CLRA, BOCW, TL, PT etc. Salary no match for the right candidate. Do revert back with your response on the same. Regards, Jessbina Machado Deputy Manager - Recruitment M: 8080874893 E : jessbina.machado@coreintegra.com

Posted 1 month ago

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