Sr. Manager, ICSR Quality - King of Prussia

The Opportunity Reporting to the Head of Risk Management Aggregate Reports & Pharmacovigilance as the Senior Manager ICSR Quality you will have Individual Case Safety Reports ICSRs accountability and be responsible for the oversight and control of the operational management and a ...

The Senior Manager, ICSR Quality will have Individual Case Safety Reports (ICSRs) accountability and be responsible for the oversight and control of the operational management and activities performed by the Global Case Management Pharmacovigilance vendor(s) for CSL Behring produ ...

Join CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. · Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience with 5 years of managerial/leadership experience · ...

This role oversees all areas of single case processing in the global pharmacovigilance database from all sources. The Medical Evaluation Lead ensures that the vendor performs case processing in accordance with regulatory guidelines and responds to specific questions or queries ab ...

CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. · ...

+We are transforming our R&D organization to accelerate innovation and create greater impact for patients CSL is building a future-ready team that excels in dynamic biotech ecosystems Joining CSL now means being part of an agile team committed to developing therapies that make a ...

CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. · ...

We are looking for a Senior Director to lead our case management function globally. · Cross-functional collaboration · The incumbent will spearhead strategic outsourcing initiatives,vendor oversight and management applying innovative approaches to achieve case management excellen ...

The Senior Director Global Pharmacovigilance is responsible for leading global medical safety strategy benefit–risk assessment signal detection epidemiology regulatory benefit–risk decision making providing strategic operational leadership across all phases product lifecycle earl ...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. · Serve as ...

The Director of Global Clinical Safety will play a key role in overall clinical safety strategy, safety assessment, evaluation and risk management of products in various stages of development as well as involvement in all safety surveillance activities and communication of regula ...

Assist with the preparation of adverse event reporting plans and other plans as required. · ...

Mindlance Inc. partners with leading employers across the country. This 6-month contract requires a Safety Scientist to assist in adverse event reporting plans, maintain administrative changes, and process AE reports according to SOPs. · ...

The Drug Safety Associate will be responsible for case processing, preparation of SUA summary and processes & procedures. · Completion of full case information on the database. · Triage of incoming cases to prioritize for daily workflow management. · Liaison with Case Receipt an ...

Review ICSRs within Global Safety Reporting scope of responsibility for reportability based on Standard Operating Procedures (SOPs), Work Instructions and internal guidance documents. Responsible for daily manual or electronic submission of ICSRs to RAs and BPs. · Make submit/no ...

The Pharmacovigilance Scientist will be responsible for the receipt and data entry of adverse event reports following company standard operating procedures. · ...

This role works in the PV Compliance (PVC) team within the Global Pharmacovigilance and Labelling department. · The role will report to the Associate Director, PV Quality & Compliance and is responsible for performing administrative compliance activities across different datasets ...

The Pharmacovigilance Associate Temp will work with other team members around the world to support and assist in the handling of safety information originating from clinical trials and marketed medicinal products. · This person will assist with managing the safety tasks performed ...

Responsible for the case processing of adverse event reports following company standard operating procedures. · ...

The Drug Safety Associate I will be responsible for the receipt and data entry of adverse event reports following company standard operating procedures. · * Case processing: 95%* May Triage and classify ICSRs for report type, seriousness, causality, expectedness/labeling and repo ...