10.0 - 12.0 years

0 Lacs

mumbai, maharashtra, india

On-site

Jd Serve as the company's subject matter expert on drug safety and pharmacovigilance Ensure compliance with Local & Global PV-relevant Heath Authority requirements Oversee PV Contracts, vendor management and PV system audits/inspections Have good understanding of signal management and benefit-risk evaluation activities Develop and implement Risk Management Plans (RMPs) and additional Risk mitigation measures Act as the primary safety liaison with country regulatory authorities and internal stakeholders Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, and Quality Assurance, marketing teams etc. Contribute to clinical trial safety strategies and protocols (e.g., prot...

Posted 1 month ago

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Clinical Research Associate Sun Pharma Laboratories Ltd

1.0 - 5.0 years

0 Lacs

bhubaneswar

On-site

As a Clinical Research Associate at Sun Pharma Laboratories Ltd in Bhubaneshwar, your responsibilities will include conducting site feasibility assessments, identifying potential investigators, negotiating study budgets, finalizing investigators and sites, and executing study-related contracts. You will be responsible for preparing and submitting study documents for EC permission, overseeing IP dispensing, managing inventory, and ensuring reconciliation. Additionally, you will play a key role in ensuring timely site initiation, monitoring, and close-out activities, as well as conducting investigator and site personnel training on study protocols, procedures, and GCP principles. Your tasks wi...

Posted 2 months ago

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Clinical Research Associate SUN PHARMA

1.0 - 5.0 years

0 Lacs

bhubaneswar

On-site

As a Clinical Research Associate based in Bhubaneshwar, your primary responsibilities will include performing site feasibility assessments, identifying potential investigators, negotiating study budgets, finalizing investigators and sites, and executing CDA and study-related contracts. You will also be responsible for preparing and submitting study documents for EC permission across centers, overseeing IP dispensing, managing inventory, and conducting reconciliations. In addition, you will play a key role in ensuring timely site initiation, monitoring, and close-out activities, as well as overseeing investigator and site personnel training on study protocols, procedures, and GCP principles. ...

Posted 3 months ago

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