Associate, Global Patient Safety Operations Job at Planet Group, Redwood City, CA

SXVRaTNwZ2tvTnU2bXBldVdiRmxkcC83aEE9PQ==
  • Planet Group
  • Redwood City, CA

Job Description


Associate, Global Patient Safety Operations 

The Opportunity:

  • Assist with the oversight of the Pharmacovigilance Contract Research Organization (PV CRO) performing case management and study support activities.

  • Assist with the management of the PV CRO to ensure compliance within the required timelines.

  • Provide vendors with relevant clinical study documents and updates.

  • Coordinate the review and filing of study plans and associated documents.

  • Coordinate the review and filing of PV CRO documents and monthly compliance reports.

  • Track and maintain well-organized department files, including listings and trackers received from CROs.

  • Support eTMF oversight of safety case files and relevant documents with PV and clinical CROs.

  • Participate and review TMF plans to capture PV and clinical CRO’s filing responsibilities.

  • Maintain PV CRO distribution contact lists and oversee Clinical CRO site contact lists.

  • Maintain meeting materials, schedule meetings, develop agendas, and track meeting minutes.

  • Assist with MedDRA and WHODrug coding impact analysis review.

  • Prepare aggregate periodic reports for departmental review and CRO distribution.

  • Assist with Standard Operating Procedure (SOP) cross-functional review in Quality Management System.

  • Perform administrative tasks to support GPS team, as needed.

  • Support GPS Operations team in other PV activities as appropriate to experience and expertise.
Required Skills, Experience and Education:

  • Bachelor’s degree in natural or health sciences or a minimum of 1 year of relevant industry experience in lieu.

  • Knowledge of Good Clinical Practice (GCP) Guidelines.

  • Experience in clinical trial conduct and safety reporting.

  • Good understanding of Software: MS Office 365 (Outlook, Word, PowerPoint, Excel), Adobe Acrobat, eTMF software, quality management systems (i.e., Veeva Systems).
Preferred Skills:

  • Experience working with CROs/vendors and management of external resources is preferred.

  • Opportunities for successful candidates will be available to learn about safety reporting in global clinical trials and other aspects of drug safety.

  • Reliable, self-motivated, focused, positive attitude, proactive and solution-oriented problem solver, able to adapt to changes in priorities and tasks.

  • Attention to detail and excellent written and verbal communication skills.

  • Demonstrate the ability to manage time, prioritize tasks, and organize information effectively to meet timelines.

  • Excellent interpersonal skills include ability to work in cross-functional team environments and with external vendors.

  • Able to create and sustain strong working relationships with remote staff use video conference and instant message, as needed.

  • Exercise discretion regarding highly confidential internal and external communications.

Job Tags

Contract work, Remote job,

Similar Jobs

Novastone CA

CEO/Entrepreneur through Acquisition Job at Novastone CA

Novastone Capital Advisors (NCA) is a global firm headquartered in Switzerland that solves succession challenges faced by small to medium-sized enterprises (SMEs) through our Operator-Led Search Fund program. NCA is looking for motivated, talented, aspirational mid-career...

Upward Health

Care Specialist Job at Upward Health

 ...team treats physical, behavioral, and social health needs when and where a patient needs help. Everyone on our team from our doctors, nurses, and Care Specialists to our HR, Technology, and Business Services staff are driven by a desire to improve the lives of our... 

Evolution Americas

In-Studio Game Presenter (Live Chat Agent Alternative) - up to $25/hr. Job at Evolution Americas

 ...City, NJ Since our launch in 2006, Evolution has pioneered the Live Casino Game Industry. We've transformed the gaming landscape by...  ...and dexterity in upper extremities Ability to see and read a chat screen from 4+ feet away Ability to communicate one way verbally... 

Addison Group

Medical Collections Specialist Job at Addison Group

 ...Job Description: This specialist will focus on resolving outstanding claims across major commercial payers such as BCBS, UHC, Aetna, and Cigna. The ideal candidate will have end-to-end experience with claims processing and be skilled at navigating payer denials, following... 

PRN Healthcare

Travel OR Registered Nurse - $2,817 per week Job at PRN Healthcare

 ...Travel OR Registered Nurse - $2,817 per week at PRN Healthcare summary: This position is for a Travel Registered Nurse specializing in the Operating Room (OR) in Jersey City, New Jersey, with a 13-week contract starting July 2025. The role involves 36 hours per week...