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PV Physician (H/F/X)

January 29th 2024

iTeos Therapeutics is a publicly-traded (NASDAQ: ITOS), clinical-stage biopharmaceutical company dedicated to extending and improving the lives of patients with cancer by designing and developing next generation immunotherapies. Based in Gosselies, Belgium and Watertown, MA, iTeos Therapeutics was founded out of the Ludwig Institute for Cancer Research (LICR) and the de Duve Institute (UClouvain) in 2011.

Mission Description

The Pharmacovigilance Physician (PvP) is responsible for providing medical and scientific support to pharmacovigilance in accordance with applicable regulatory guidelines/requirements and company Standard Operating Procedures (SOPs). 

Primary responsibilities include the monitoring of ITeos products’ safety profile through life cycle, medical review of adverse events, safety surveillance, and coordination of signal detection and analysis. 

Additional key responsibilities include:

  • supporting the clinical development teams to ensure sponsor compliance with medical monitoring of ongoing clinical trials and provide safety input into protocol development and amendments.
  • support the global regulatory function in meeting regulatory requirements by providing medical/safety input into protocol amendments, annual development updates (DSUR), and responses to ad hoc questions from regulatory authorities regarding safety matters in planned and/or ongoing studies. 

 

MAIN RESPONSIBILITIES:

  • Provide oversight and medical review of individual safety case reports arising from iTeos Clinical Studies and/or other relevant sources to required Regulatory standards and timelines: 
    • Review all SAEs and potentially reportable cases (SUSARs/INDSRs), 
    • Liaise closely with clinical development physicians to ensure all necessary safety/clinical/laboratory information is available to enable comprehensive medical assessment of reported SAEs and potential SUSARs/INDSRs,
    • Confirm seriousness, expectedness and relatedness assessments as the Sponsor representative,
    • Issue queries as appropriate,
    • Review and confirm the analysis of similar events,
    • Confirm closing cases when queries and reporting are completed.
  • Attend the clinical development led monthly (study specific) Safety Management Team meetings:
  • Assess all per protocol emergent safety information from ongoing individual studies for the previous month and consider this information in the context of the known cumulative safety profile to detect any possible new emergent safety information,
  • Work with the clinical development physicians to ensure compliance with the individual study Safety Monitoring Plan and assist in demonstrating compliance with the Sponsor’s responsibilities for safety oversite of an ongoing study.
  • Lead the Safety Review Teams (SRT)for clinical assets in development:
    • Set the agenda for quarterly and ad hoc SRT meetings,
    • Prepare and present the safety data,
    • Ensure minutes are completed and appropriately archived,
    • Ensure that actions are identified, assigned and completed,
    • Lead the assessment and management of emerging safety signals.
  • Present at the Joint Safety Review Team for belrestotug (EOS-448) :
    • Support the iTeos JSRT co-chair to set the agenda for each joint meeting and review cases with the internal team prior to each joint meeting,
    • Co-lead the assessment and management of safety signals.
  • Be an active participant in monthly Product Development Team meetings and Clinical (study) sub-team meetings for nominated iTeos development assets to ensure PV/Safety perspectives are considered in all key clinical decision-making involving planned or ongoing studies.
  • Other activities include, but are not limited to:
    • Support iTeos’ process for signal management and the detection/evaluation of trends and safety signals from any source,
    • Responsible for the coordination of the signal detection process,
    • Responsible for preparing responses, including benefit-risk assessment, to requests from Regulatory Authorities,
    • Drive proactive implementation of risk management initiatives in accordance with global regulatory requirements, 
    • Review key project documents (including protocols, amendments, IB, DSURetc.) from a safety perspective for all projects,
    • Provide medical guidance and training to pharmacovigilance team members in medical/clinical safety aspects, 
    • Maintain knowledge and understanding of safety related regulations and guidelines,
    • Preparation and maintenance of PV Working Procedures and SOPs,
    • Participate and support during Regulatory Authority inspections and Audits either internal or from Business Partners,
    • Be an ambassador for the PV function in iTeos.

A key aspect for success of the role will be the ability to be comfortable with, and work to, tight timelines and to work well within multi-functional teams as well as being able to lead, where necessary, on important safety matters that may affect individual clinical trials clinical and/or development programs. 

Candidate profile

  • University Degree in Medicine and Surgery.
  • At least eight years’ experience in clinical research in the pharmaceutical industry.
  • At least five years’ experience as a Pharmacovigilance / Drug Safety Physician.
  • Direct experience with oncology, small molecule drugs is highly beneficial.
  • An excellent knowledge of EU and US safety related regulations.
  • An excellent understanding of GxP guidelines relevant to drug safety.
  • A proven ability to work independently and prioritize work effectively with predisposition to team working and compliance.
  • A proven ability to communicate and interact with collaborators and external consultants/business partners. 
  • A positive and pro-active attitude and ability to interact smoothly and professionally with internal and external partners in a global environment. 
  • Excellent organization skills and ability to handle multiple competing priorities within tight timelines.
  • Excellent presentation and communication skills.
  • Good knowledge of standard computer systems. For safety databases, knowledge of ARGUS is an advantage.
  • Fluency in verbal and written English is essential.
  • The role is home based but iTeos has offices in the Brussels, Belgium area and Boston, MA area with travel when required. 
  • Ability and willingness to travel domestically and internationally.
  • Ability and willingness to travel domestically

Offer

  • A stimulating position within a high-potential innovative biotech company.
  • The opportunity to work in a science-driven, dynamic, respectful, and professional environment.
  • A challenging scientific and business growth in which you get to bring your knowledge and skills.
  • An employment agreement contract with an attractive salary package in line with the position responsibilities and your experience.

Contact Details

Please send your CV together with an adapted cover letter to the following address: jobs@iteostherapeutics.com. Please, mention the reference PvP in the mail object. Your application and related information will remain strictly confidential.

For this open position in Belgium, we closely collaborate with Hobson Prior (Recruitment & Selection company). Your application will be automatically forwarded to them. We, together with Hobson Prior, will keep all your data confidential (GDPR compliant approach).