Sandoz Medical Safety Associate Vacancy – D Pharma/M Pharma Apply
Sandoz pharma job opening. Medical Safety Associate. M Pharma job opening, Medical Safety Associate post vacancy. D Pharma & M Pharma job opening 2022. Pharma job. Candidates with a master’s in pharma may apply for the job vacancy at Sandoz for the post of Medical Safety Associate.
Job Id: 364946BR
Job Title: Medical Safety Associate (Sandoz)
Eligbility Criteria
• Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD or Life sciences graduate.
• 1-2 years in patient safety. Experience in safety document or medical writing including experience coding with MedDRA and WHO dictionaries
• Good understanding of clinical trial methodology, ICH GCP, GVP guidelines and medical terminology. Attention to detail and quality focused
• Good communication skills, and the ability to operate effectively in an international environment
• Good understanding of Human physiology, pharmacology, clinical study objectives, and the drug development process
• Good presentation skills; Good computer skills including, but not limited to, creation of spreadsheets, templates, presentations and working with safety databases/applications
Your responsibilities include, but are not limited to:
• Provide support according to the needs for delivery activities, co-authoring safety
documents and assisting in providing safety input to regulatory and clinical documents and ad hoc Health Authority queries.• Archiving all safety documentation as per respective policies, guidance, and procedures. Updating the Medical Safety SharePoint, uploading of documents, tracking and planning list updates
• Verification and update of respective PS archiving system (incl. review, update, management); Monitoring of the compliance. Support in organizing response to queries from Countries and regions and other functions outside medical safety
• Support in developing, updating, and implementing global procedures to ensure compliance. Management and maintenance of relevant Global PS databases/sharepoint.
• Prepare and submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to HA, development and implementation of corrective action(s) as needed.
• Preparing metrics as required and agreed with the manager. Support the Group Head, Medical Safety Operations/Medical Safety Group Lead/ Associate director Global Risk Management/ Associate director Quantitative safety and MedDRA in day to day operations as per assigned responsibilities
• Support Literature review for PSUR inclusion and assessment of literature for signals. Reviewing HA assessment reports and engaging and supporting the appropriate safety leads to address the questions by the HA
• Support in preparation of responses to internal safety requests and contribute to responses to external safety queries
Apply Online
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