Luminary Group is partnering with a leading pharmaceutical consulting company to hire a dedicated Safety Physician specializing in Oncology for their operations in China. As a Safety Physician, you will play a crucial role in ensuring the safety and efficacy of our client's oncology products.
Responsibilities:
- Oversee the safety management of oncology products throughout their lifecycle.
- Conduct safety surveillance and evaluation of adverse events and other safety data.
- Contribute to the development and implementation of risk management plans.
- Provide medical input and expertise during safety reviews and signal detection activities.
- Collaborate with cross-functional teams to review and interpret safety data for regulatory submissions.
- Conduct medical assessment of individual case safety reports and contribute to safety aggregate reports.
- Monitor and communicate emerging safety concerns and trends to internal and external stakeholders.
- Participate in safety-related regulatory interactions and support regulatory inspections and audits.
- Stay updated with the latest developments and regulations related to oncology drug safety.
- Collaborate with medical affairs and other teams to ensure safety information is effectively communicated to healthcare professionals and patients.
Requirements
- Medical degree (MD) with specialization in oncology or related field.
- Minimum of 3 years of experience in pharmacovigilance or drug safety, preferably in the oncology therapeutic area.
- Strong knowledge of pharmacovigilance practices and regulations in China.
- Understanding of oncology drug development and regulatory requirements.
- Experience in safety evaluation of adverse events and signal detection.
- Familiarity with risk management plans and safety aggregate reports.
- Effective communication and collaboration skills to work with cross-functional teams.
- Ability to analyze and interpret complex safety data.
- Proficiency in both written and spoken Chinese and English languages.
- Able to work independently and prioritize tasks effectively.
- Authorization to work in China.
