Manager/Sr. Manager Patient Safety Quality and Compliance

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Summary:

We are searching for a creative, resourceful, integrative thinker for an important role that will be

responsible for safety quality and compliance activities.

 

The Manager/Sr. Manager, Safety Quality and Compliance will be responsible for supporting the development and management of quality infrastructure and processes pertaining to safety and pharmacovigilance. The candidate will contribute to activities such as inspection readiness, internal audits and global regulatory inspections, assist with strategies for all agreements where safety activities and input is required, and building robust, compliant processes to ensure the company’s success in continued growth and expansion. This position requires a candidate with strong cross-functional skills and communication, a desire to help the team meet fast-paced growth into global territories and be self-motivated.

 

Responsibilities:

Where applicable work independently and collaboratively with the Associate Director, Safety Quality and Compliance to perform the following:

• Assist with the development and implementation of best practices to ensure safety systems and processes are compliance with global regulations.
• Review new regulatory requirements and perform impact analysis to existing processes.
• Establish key performance metrics to measure compliance and data quality.
• Develop and deliver periodic safety system compliance reports, including relevant metrics, to key stakeholders and senior leadership.
• Contribute to due diligence and/or pre-qualification activities of vendors needed to support safety activities.
• Support the global strategy and compliance requirements for safety data exchange agreements (SDEA)/PV agreements (PVA), Investigator Sponsored Trials (ISTs), and Expanded Access Programs (EAPs), ensuring compliance with global regulations.
• Incorporate industry leading innovative initiatives aimed at improving effectiveness of surveillance, signal detection and risk mitigation strategies for both marketing and developing therapies.
• Serve as the safety subject matter expert on cross-functional committees relating to training and standards within the company.
• Support the R&D Quality organization with internal and external safety audit and inspection activities.
• Review and analyze audit, inspection and CAPA data to identify compliance trends and areas of exposure related to safety.
• Work closely with R&D Quality, Safety Operations, etc. to manage CAPA activities related to R&D Safety department (initiation and preparation of investigational activities).
• Support the organization global submission activities for product approval.
• Supports the creation of systems and processes [(including EU PSMF, reviewing and/or writing Standard Operating Procedures (SOPs) and Work Instructions (WI)] to support international business expansion efforts, in collaboration with the AD, Safety Quality and Compliance.

 

Qualifications
• Bachelor’s level degree in nursing, pharmacy, or other health care related field.
• 4 years in the pharmaceutical industry setting; 2 years’ experience working in Safety and Pharmacovigilance, specifically within quality and compliance.
• Oncology experience is preferred

• Extensive experience in safety quality systems, compliance monitoring, and the development and maintenance of standards and training programs.

• Strong knowledge and experience with available drug safety database systems, document management systems, and QC tools, as well as MedDRA.

• Expert knowledge of FDA, EMA, Asia-PAC, and ICH regulations and guidelines.

• Demonstrated problem-solving and critical thinking skills.

• Excellent interpersonal, communication, analytical, and organizational skills.

• Demonstrated ability to work effectively in a dynamic, complex, and fast-paced team environment.

• Track record of strong personal performance combined with demonstrated ability to build and lead high performing teams.

• Strong people and project management experience. 

#LI-Remote

 

3928 Point Eden Way I Hayward, CA 94545 – Arcus Biosciences is an equal opportunity employer

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