Pharmacovigilance Scientist I - Safety Strategy & Reporting

Makro Scientific; South San Francisco (CA); Presencial; USD 70.000 - 95.000; Jornada completa

Descripción de la vacante

A leading staffing solutions provider is seeking a Scientist I in South San Francisco, CA, for an 8+ month contract. The role involves contributing to pharmacovigilance and risk management, preparing safety reports, and supporting regulatory submissions. Ideal candidates have strong knowledge of international drug regulations and prior industry experience in drug safety or clinical development. An MS or MD, PhD or PharmD is preferred. This position offers a unique opportunity to make a significant impact in life sciences.

Formación

• Strong knowledge of international drug regulation including GCP, GVP and GMP.
• Prior industry experience in drug safety, clinical development or medical affairs is desirable.
• MD candidates - clinical practice experience (at least 3 years preferred, may include residency).
• Good knowledge of pharmacovigilance practices.
• Good knowledge of US and EU pharmacovigilance regulatory requirements.

Responsabilidades

• Contribute to Pharmacovigilance and Risk Management planning for designated products.
• Prepare and review periodic safety reports in accordance with regulatory requirements.
• Support the preparation and maintenance of safety sections of the Company Core Data Sheet.
• Conduct/support signal detection and evaluation according to SOPs and guidelines.
• Provide safety content review of clinical protocols and related documents.
• Contribute to regulatory agency submissions by reviewing safety data.
• Participate in or provide input for Drug Safety Monitoring Boards meetings.
• Develop a clear understanding of the safety issues and a thorough knowledge of the drug's mode of action.
• Timely development of the clinical safety portions of a product development plan.

Conocimientos

Strong knowledge of international drug regulation including GCP, GVP and GMP

Prior industry experience in drug safety, clinical development or medical affairs is desirable

Good knowledge of pharmacovigilance practices

Good knowledge of US and EU pharmacovigilance regulatory requirements

Educación

MS or MD, PhD or PharmD Preferred, or equivalent qualification

Descripción del empleo

A leading staffing solutions provider is seeking a Scientist I in South San Francisco, CA, for an 8+ month contract. The role involves contributing to pharmacovigilance and risk management, preparing safety reports, and supporting regulatory submissions. Ideal candidates have strong knowledge of international drug regulations and prior industry experience in drug safety or clinical development. An MS or MD, PhD or PharmD is preferred. This position offers a unique opportunity to make a significant impact in life sciences.