Ref #: 37415

Employment type: Permanent - Full-Time

Location: Germany

Posted: 04-May-2022

Description

We are searching for a Drug Safety Manager (Clinical Safety Manager / Pharmacovigilance Manager) to be located from home anywhere Europe. There is a preference for the candidate to be located in Germany, however other locations throughout Europe will be considered.

ICON:

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.


RESPONSIBILITIES

Key Accountabilities

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.
In addition, the Manager Clinical Safety Operations is accountable for the development, optimization, implementation, and documentation of appropriate processes to ensure Pharmacovigilance compliance in the area of responsibility. Define process KPls, implement, monitor and communicate performance and develop solutions for continuous improvements.
Ensure compliance by vendors involved in clinical trials and non-interventional post¬ authorization studies in close collaboration with the Vendor Manager

The Manager Clinical Safety Operations is responsible and accountable for:

• 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, 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 and alignment of guidelines and processes related to clinical trial safety management with existing GDS processes

Strategic Impact

Impacts company compliance with worldwide regulatory safety reporting requirements.

Cooperation

Interfaces with other Departments/Functions:

• GPS Operations functions, especially Vendor Manager and Case Processing
• All Global Drug Safety internal groups, including LPSSs
• Local Data Entry sites
• Quality Assurance
• Medical Affairs
• Clinical Operations


External Interfaces

• CROs/Vendor
• Clinical trial investigators
• Business/development partners


REQUIREMENTS

Professional Experience
• 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

Job Specific Competencies & Skills

• Ability to work in intense, fast paced, matrix ed, multinational work environment Strong oral and written communication skills
• Fluent in English language, a 3rd language is an asset
• Ability to effectively communicate with employees, colleagues, and global counterparts’
• Positive motivator
• Team worker
• Customers and result orientation

Education/Languages
• Health Care Professional with extensive work experience in pharmacovigilance area, clinical development, project management, IT Systems
• Fluent in written and spoken English
• University degree is an advantage or relevant professional experience equal to scientific studies
• Proven project and process management skills


Why this vacancy is right for you:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Would you like to know more? Please contact the lead recruiter, michael.kellitt@docsglobal.com


Michael Kellitt
Senior Recruitment Consultant DACH
+49 89 666 105288
michael.kellitt@docsglobal.com
Konrad-Zuse-Platz 11, 81829 München