Offer summary

Qualifications:

Medical degree with specialization in oncology or related field., Minimum 3 years experience in pharmacovigilance or drug safety, preferably in oncology..

Key responsabilities:

Oversee safety management throughout product lifecycle.

Conduct safety surveillance, evaluation, and medical assessment of adverse events and safety data.

Contribute to risk management plans and regulatory submissions.

Monitor and communicate emerging safety concerns and trends, participate in regulatory interactions.

Stay updated with oncology drug safety developments and regulations, collaborate for effective safety information communication.

Job description

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.