Company: Planet Pharma Staffing Limited
Location: Leiden, Netherlands
Closing Date: 14 Nov 16
Salary (£): Competitive
Planet Pharma are recruiting an Advanced Safety Analyst / Writer on behalf of our client, an international Pharmaceutical Company in Leiden, The Netherlands!
Role: Advanced Safety Analyst / Writer – International Pharmaceutical Company
Location: Leiden, The Netherlands
Job Type: Freelance – 1-year contract (ASAP start)
Planet Pharma are recruiting an Advanced Safety Analyst / Writer on behalf of our client, an international Pharmaceutical Company in Leiden. This is an exciting opportunity for an experienced PV / Safety professional looking for a new contract opportunity in an innovative and growing company!
Applications from anywhere in the EU welcome!
- Create and maintain the Global periodic schedule by interfacing with external departments
- Work with affiliates and local health authorities to understand periodic reporting requirements
- Negotiate with local health authorities to leverage existing reports and periodicities to meet the periodic reporting requirements
- Regularly work with EU-Regulatory Affairs to update and maintain the global periodic schedule
- Project management for Aggregate Safety Assessment (ASA) initiatives, maintain ASA SharePoint (SPS), take meeting minutes, etc.
- Coordinate periodic reports, work with external global vendor in the development of periodic reports
- Work with product responsible persons/ physicians and other stakeholders to ensure that periodic reports comply with the timelines and regulations
- Assist project teams in updating global and local controlled documents
- Manage the controlled document approval process (review, approval, signatories)
- Perform writing and project management activities for documents (e.g., PBRER, DSUR) including formatting text, tables, and appendices, apply styles, hyperlinking, versioning, Table of Contents, etc.
- When necessary, manage the project timelines and deliverables of aggregate report projects (e.g., PADERs) working closely with the Safety Team
- Conduct quality control (QC) review, including verification of data against approved supporting documentation/sources of medical/scientific information for aggregate reports (e.g., PBRERs, DSURs, etc.)
- Significant relevant PV experience required
- Experience writing periodic reports, QC experience, process oversight experience, and process creation experience
- Hands on, relevant experience with controlled documents
- Thorough knowledge of GVP modules and ICH PV regulations
- Knowledge of PV SOPs and/or processes required
- Proven project management skills and attributes evidenced by detailed project management experience
- Ability to work effectively in a matrix setting to resolve issues and achieve common goals
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