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

Weis Markets

Tractor Trailer Driver Job at Weis Markets

 ...monitor its safe distribution throughout the trip. Maintain tractor cleanliness standards by washing, cleaning, and vacuuming. Adhere...  .... Qualification Requirements Class A Commercial driver's license and 50,000 miles of driving experience. Weis Markets... 

Altera

Chief Information Security Officer (CISO) (San Jose) Job at Altera

 ...Chief Information Security Officer (CISO) Apply locations San Jose time type Full time posted on Posted 2 Days Ago job requisition id R00594 Job Details: Job Description: Role Overview: We are seeking a dynamic and experienced Chief Information Security Officer... 

Coalition Technologies

Magento Developer Job at Coalition Technologies

 ...Have:*** An expertise in PHP, MySQL, HTML5, and CSS3.* A portfolio with live links to sites that you have developed previously (preferred).* A Magento Certification (preferred).* Expertise in other platforms such as WordPress (preferred).* The ability to convert... 

A2O Entertainment USA, Inc

Talent Casting Manager Job at A2O Entertainment USA, Inc

 ...Job Description Job Description Salary: Talent Casting Manager A2O Entertainment is a Global Culture and Technology Enterprise...  ...actors for the role by reaching out to the appropriate talent agencies. Coordinate casting calls, auditions, interviews, callbacks,... 

ManTech

Program Security Officer 2 Job at ManTech

 ...ManTech seeks a motivated, career and customer-orientedProgram Security Officer 2 PSO 2 to join our team in Chantilly, VA. Responsibilities include but not limited to: Provides advice and assistance regarding a range of security issues and concerns to government...