Ref #: 24383

Employment type: Permanent - Full-Time

Location: Germany, ideally Frankfurt/Main area, Home Office possible.

Posted: 01-Oct-2020

Description

Summary:

For one of the most successful global players in the pharmaceutical industry DOCS is hiring a Clinical Safety Operations Manager (m/w). If you have experience in and want to develop further into global Clinical Safety Management from a sponsor’s perspective and by doing so, helping to improve treatment of today’s biggest challenges to public health, than this might be for you.
The role of the Manager Clinical Safety Operations is to contribute to effective and efficient proactive safety strategies for the assigned processes and delivery of operational safety aspects. This includes the provision of key expertise and guidance to concerned Global Drug Safety functions and other functions within the company, as well as vendors for safety operational tasks.


Key responsibilities:

• Process for the medical safety follow -up queries for ICSRs from interventional clinical trials and non-interventional, post -authorization studies
• SAE reconciliation activities (interface to Global Data Management) for company sponsored phase I to IV clinical trials and non-interventional post -authorization studies
• Process for reconciliation of ICSRs exchanged with business/development partners and other sources (Global Medical Information, Merck Quality)
• Maintenance of the study protocol library (with assignment of IM P/ non -IMP) and the company product dictionary in the global safety database (ARISg)
• Review of safety sections of trial related documents (e.g. Drug Safety Manual/ Safety Processing Plan, Trial Oversight Plan, SAE reconciliation plan)
• Contribute to trial specific resource and budget planning
• Contribute to defining and implementing of clinical trial safety related activities in the alliance with relevant partners/service providers of Merck and alignment of guidelines and processes related to clinical trial safety management with existing GDS processes

Education & Experience

• University degree is an advantage or relevant professional experience equal to scientific studies
• Health Care Professional with extensive work experience in pharmacovigilance area, clinical development, project management, IT Systems
• Several years of professional experience (5-7 years) in Drug Safety/Clinical Trial Safety Management
• Sound understanding of regulations relevant to the safety of drugs in development and post authorization
• Excellent communication skills in an international environment
• Intercultural experience through successful collaboration in matrix teams
• Fluent in written and spoken English
• Proven project and process management skills

Conditions:

• Permanent Contract
• Full time, ideally office based in Frankfurt/Main area. Home office options can be discussed
• Great pipeline of studies
• Top 4 global player in the pharmaceutical industry
• Contribution to pension scheme


Why this vacancy is right for you:

We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a company dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life.

Interested? Please submit your CV to Roger.BravoMendez@docsglobal.com or via our homepage www.docsglobal.com. We are looking forward to your application.