LabCorp Pharmacy & Chemistry Job Opening – Drug Safety
LabCorp project manager job opening 2022. Pharmacy and chemistry job opening 2022. LabCorp job vacancy, Candidates with diploma degree in pharmacy and bachelors degree in chemistry and pharmacy may apply for the job opening at Labcorp, Intrested and eligible candidates may check out all the details on the same below:
Job Title: Project Manager – Drug Safety (Medical Devices)
Category Project Management
Location Bangalore, India
Job Id: 2261357
Job Type Full-Time
- PharmD + 2-3 yrs relevant experience** (1-2 yrs safety experience) For PharmD, a one-year residency of fellowship can be considered relevant experience.
- Degree preferred to be in one or more of the following disciplines: Pharmacy, Chemistry.
- Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions. **Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance. EudraVigilance Certification preferred
Must have experience with Medical Devices
The Drug Safety Project Manager is a remote position based in Canada, open to local candidates only. Must have experience in Drug Safety with Medical Devices.
- Provide leadership and management of global or regional projects ensuring that communications and processes are harmonized for assigned projects, monitor and manage the workflow for assigned projects to ensure all deadlines are met and compliant safety reporting in accordance with International reporting regulations, Standard Operating Procedures (SOPs)
- Work closely with the clinical operations and project management groups to ensure all PSS activities are performed according to the regulatory and contractual requirements. Provide oversight of the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial for assigned projects.
- Responsible for making decisions regarding adverse event reporting within the guidelines of each assigned project.
- Provide oversight and management of EudraVigilance activities for assigned projects. Maintain a strong understanding of safety database conventions or client specific database conventions and system functionality. Provide oversight and/or perform signal detection and trend and pattern recognition activities, as required for assigned projects.
Preparation of Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency.
- Provide oversight and/or preparation of timely pharmacovigilance reports for products and safety issues, including but not limited to Individual Case Summary Reports (ICSR) of Serious Adverse Events (SAEs) and aggregate reporting, monitor and manage project deliverables regarding contract assumptions; identifying out of scope work or potential to run over budget.
- Contribute to the generation and review of Time and Cost Estimates for PSS business, generation of monthly status, and other project-specific reports ensuring the quality and accuracy of metrics and data provided. Attend client meetings and liaise with clients where appropriate.
- Provide PSS project training for assigned projects for PSS, Clinical Operations/Project Management, Client,s and Investigators as required. Prepare and participate in audits by the client or a regulatory agency.
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