Patient Safety Lead - Global Pharmaceutical - Permanent, BE

Reference: RS181220C

Expiry Date: 18-06-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Belgium

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Job Description

Patient Safety Lead - Global Pharmaceutical - Permanent, BE

To strengthen my clients Global Patient Safety Group, we are looking to fill the position of Patient Safety Lead in a number of different TA.

About the Role

You will be responsible for:

  • Global oversight of safety risk management activities for assigned product(s) including clinical safety, signal detection, signal management, aggregate reports, risk communication, risk mitigation and risk management
  • Accountability to lead, in a matrix structure, a cross-functional Benefit Risk Team (BRT). Ensure that all relevant emerging data are assessed, acted upon, and integrated into the benefit risk assessment in a timely manner
  • Providing strategic safety leadership for assigned product(s) across various cross-functional teams (e.g. life-cycle product team, labelling team) and governance bodies (e.g. Benefit Risk Board, Global Labelling Committee)
  • Collaborating with stakeholders within the organization (e.g. local safety officers, QPPV, clinical development) and outside of organization (e.g. Key Opinion Leaders and regulators) to ensure the safe use of client products.

About You

You should have:

  • An MD/PhD/PharmD qualification or the equivalent
  • Substantial experience within the pharmaceutical industry as well as a proven track record in scientific and project team leadership. Along with a good understanding of the global pharmacovigilance and safety requirements for non-clinical development, the registration process and onto the market
  • Good knowledge of relevant regulations and proven evidence of effective delivery of high quality documents. As well as relevant concepts in data management and systems, epidemiology and statistics
  • The ability to understand science and biology and understand the significance of preclinical findings when planning use in man. Act without oversight in most circumstances as well as provide key input to difficult or sensitive projects
  • Be able to identify risks and propose corrective actions in complex and critical situations and the ability to a multifunctional team as well basic project management skills to allow management and delivery of multiple complex deliverables within tight timelines
  • The technical skills and capabilities to author and contribute to large complex documents within document management systems and the knowledge of relevant concepts in health care, human biology, data management and systems, epidemiology, pharmacology, pharmacovigilance, drug development and statistics
  • Have expertise and good knowledge of all  phases from FIM to post approval and relevant legislations and guidelines.

If this sounds like you please do get in contact.

To Apply!

To apply for this role, please contact me, the Clinical & Medical Hiring Lead, asking for Roland Schnapka, on +44 (0)207 801 3387 or send a full CV to roland@advtalent.com. Alternatively, please press the red “Apply for position” button and follow the registration process.

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