Assistant manager, Pharmacovigilance, Epidemiology & Risk Management PharmaLex

0.0 years

0 Lacs

noida, uttar pradesh, india

On-site

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Searching literature databases and screening database hits for new safety data on medicinal products, reportable and non-reportable cases and signal detection. Writing Periodic Safety Update Reports (PSUR) in PBRER format, Development Safety Update Reports (DSUR), Addendum to the Clinical Overview (ACO), Pe...

Posted 3 weeks ago

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Head Pharmacovigilance India Abbott

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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Head Pharmacovigilance India Abbott Healthcare

10.0 - 12.0 years

0 Lacs

mumbai, maharashtra, india

On-site

JOB DESCRIPTION: 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 pro...

Posted 2 months ago

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