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- ...(eCTD), Employee Training Programs, Internal Customers, Life Science, Management Process, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Product Approvals, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance...
- ...subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Per the Clinical Monitoring/Site Management Plan (CMP/SMP):Assesses site processes. Conducts Source Document Review...
- .... Local laws & HCBI guidelines, Foreign Corrupt Practices Act (FCPA), Policy of business conduct and other J&J policies. 2. Pharmacovigilance rules notifying within company regulations about Adverse Events & Product Quality Complaints. 3. Quality and compliance practices...
- ...information booths and gathering competitive intelligence. Receive, report, and transmit adverse events in line with company pharmacovigilance procedures, and ensure Risk Management Plan implementation. Uphold compliance, ethical leadership, and safety standards in...
- ...all required GDP trainings and maintain audit readiness. ~Partner closely with Commercial, Supply Network Operations, Quality, Pharmacovigilance , Manufacturing Sites, Medical Affairs and Global Regulatory Affairs. ~Ensure effective coordination between regulatory...