Principal Medical Pharmacovigilance Scientist

Novotech

  • Shanghai
  • Permanent
  • Full-time
  • 2 months ago
Job Description:Purpose of Principal Medical Pharmacovigilance Scientist or Senior Medical Pharmacovigilance Scientist role is to monitor on the safety of patients participating in clinical trials and post marketing surveillance. This role involves the medical review and evaluation of adverse events, signal detection, risk management and contribution to safety related documents and activities.Responsibilities:
  • Supporting senior physicians in safety related activities.
  • Assist with managing project-specific activities which may include:
  • Review of safety project plans, review of medical coding and safety narratives, assessment of causality and expectedness of an ICSR, review of monthly or periodic safety reports, review and support safety report submissions as required, literature strategy preparation, risk management plan review and identification of safety signals.
  • Participate in clinical study reconciliation activities, as required/ as requested by client.
  • Liaison with medical monitors, clients, and study teams as appropriate to clarify information required for case processing.
  • Participation in inspection/ audit related activities; Assistance in preparation or implementation of corrective/ preventative actions relating to safety pharmacovigilance.
  • Assist and participate in global/ program level governance committee reviews.
  • Provide technical medical support to the safety team through own medical knowledge.
  • Any other responsibilities as assigned by the line manager.
Education Qualification:
  • Medical degree is required, and MD or equivalent will be an advantage.
  • Qualification by experience or certification in clinical trials or pharmacovigilance will be an advantage.
Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.About Us:Novotech is a global full-service clinical Contract Research Organization (CRO).Headquartered in Sydney, Australia, Novotech has 34 offices across Asia-Pacific, North America, and Europe. Novotech employs over 3000 employees and has over 5000 site partnerships and the resources and infrastructure to scale regionally and globally as clinical programs advance.Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.About the Team:At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences.At Novotech you will work alongside empowered teams with a shared commitment to success.
  • Strategic vs transactional mindset.
  • Ability to gain insights and make proactive decisions quickly.
  • Culture that fosters partnership and collaboration, where every voice is heard and valued.
  • Ongoing support from senior stakeholders and leadership team.
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Novotech