Job Description

Company Description
We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
PSI's business is about conducting clinical research of novel medications. We work at the interface of R&D, pharmaceutical industry and healthcare science and provide services to big and mid-sized pharmaceutical companies. We help our clients to generate data about safety and efficacy of medications and bring the best ones to market. By conducting global clinical research trials, PSI makes cutting-edge treatment available in drugstores all over the world and helps patients with serious medical conditions to improve or even save their life. Help us to make sure that PSI medical and business documents are clear to patients, physicians, regulatory authorities, and clients.
We offer an inspiring story of the company that has grown organically from a handful of countries to global presence. PSI is a mature company with standards and practices, but we do not stand still. Every day, there is a figurative Everest to climb, and you will not get bored here.

PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being.
Responsibilities:

• Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters
• Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations
• Review and analysis of clinical data to ensure the safety of study participants in clinical studies
• Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments
• Address safety issues across the study from sites and the study team
• Review listings for coded events to verify Medical Dictionary for Regulatory activities
• Participate in bid defense meetings
• Assist in Pharmacovigilance activities
• Identify Program risks, and create and implement mitigation strategies with Clinical Operations
• Ability to organise and lead clinical development advisory boards and safety monitoring boards
• Ensure Study team compliance with local regulatory agencies, ICH and GCP guidelines
• Review and sign off clinical documents with respect to medical relevance

As part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them.
Qualifications

• Medical Doctor (MD) degree with Board Certification/Specialization in (Oncology, Gastroenterology, Infectious Disease or Onco-Hematology) is an essential requirement.
• Familiar and comfortable with clinical concepts, practices and local regulations regarding clinical research trials experience with local health authority interactions leading to drug approval strongly preferred.
• Ability to interact with and train clinical monitors and physician investigators, and build constructive, trusting and respectful relationships with colleagues at all levels within and outside the organisation.
• Must possess excellent leadership, communication, presentation, and organisational skills and be able to exercise sound critical thinking and problem-solving skills and execute position responsibilities with minimal guidance.
• Proficiency with MS Office applications.

Additional Information
Join our highly dedicated team of clinical research professionals with +250 Medical Doctors onboard, and make a tangible difference within a professional and energetic organization founded by scientists.