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Job Details

Advanced Safety Analyst / Writer – International Pharmaceutical Company, Leiden

Company: Planet Pharma Staffing Limited
Location: Leiden, Netherlands
Reference: MH-SafetyAnalystNDL
Closing Date: 14 Nov 16
Type: Contract
Salary (£): Competitive

Job Summary:

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

Apply for this job: Advanced Safety Analyst / Writer – International Pharmaceutical Company, Leiden

Contact Information:

Address:  Head Office
10 Greycoat Place, London,
Tel:  +44 203 868 1000
Website:  Visit Our Web Site

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