Safety Data and ICSR Professional

A new vacancy has opened for a Safety Data and ICSR Professional for a 6-month contract at a world-wide pharmaceutical organisation focused on the research and development of novel medicines and marketing them once they have been developed.

Job Responsibilities:

• Profound knowledge of assigned topics and regulations within ICSR case processing, & strong broad knowledge across the end to end ICSR process in line with the expectations of the key stakeholders.
• Accountable leader, who role models proactive, self-motivated process development and issue management.
• Maintains procedural documents and training, devises strategies and solutions to contain issues, mitigate risks and develop solutions, is transparent with risks identified and escalates to BPO/GPO network where necessary.
• Oversight of service providers via relationship management, and metrics and analysis.
• Communicate expertise in a rational and structured approach to influence colleagues, and to articulate the process and approach to external stakeholders e.g. during regulatory inspections.
• Independent decision-maker, making compliant and pragmatic decisions based on seeing.
• Critical thinker who can see the bigger picture in order to connect processes, data, ideas and people.
• You are self-motivated to learn about new data sources, new regulations, and seek to co-create new solutions when required e.g. learning about novel artificial intelligence tools to develop new approaches with 'humans in the loop'.
• Effective leadership of complex initiatives with multiple stakeholders, with the ability to investigate and creatively solve problems and simplify, whilst meeting customer needs.
• You act on behalf of the whole company and is open and supportive in co-located and virtual, matrix teams.
• Adaptable with the ability to handle ambiguity and continuously reprioritise to focus upon the most impactful work to our stakeholders and patients.

Requirements:

• Evidence of advanced learning e.g an undergraduate degree, however on-the-job pharmacovigilance experience would be equally considered.
• Ideally you would have demonstrated experience in a breadth of areas pertaining to pharmacovigilance, and pharmacovigilance legislation; good knowledge of international regulations (ICH, EU GVP Modules, FDA) and an understanding of the pharmaceutical industry (product development and the commercial environment) and of rapidly-evolving personalised healthcare environment and ecosystem.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.