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

CoMark

Entry Level Marketing Job at CoMark

 ...Entry Level Marketing As a part of our Entry Level Marketing team, you will be responsible for providing retail sales, marketing...  ...and surpass weekly team and client goals. We are looking to hire IMMEDIATELY for this on-site role. LOCAL APPLICANTS ENCOURAGED TO APPLY... 

JPMorgan Chase & Co.

Sr Manager of Software Engineering Job at JPMorgan Chase & Co.

 ...Provide overall direction, oversight, and coaching for a team of entry-level to mid-level software engineers that work on basic to...  ...history spans over 200 years and today we are a leader in investment banking, consumer and small business banking, commercial banking, financial... 

Locum Tenens

Physician Job at Locum Tenens

 ...locations, and travel, lodging, and malpractice insurance are provided. Dates Needed: February/March start - ongoing Case Load/PPD: 28,000 and 15,000 annual volumes Shift Type: Day Shift;Night Shift Assignment Type: ER Assignment Duration: Locums Call... 

West River Health Services

Laundry Aide Job at West River Health Services

 ...established company policies and procedures. FUNCTIONS: Pick up, weigh, wash, dry, iron, fold, stack andhang resident and facility laundry. Ensure that residents clothes are properly identified and labeled with indelible ink pen. Report losses and damages of... 

Lorien Health Services

Housekeeper / Laundry Aide Job at Lorien Health Services

Lorien Encore is looking to hire a Housekeeper and laundry aide to join our existing cleaning staff. Our Housekeepers are the team behind the sparkle in our buildings! Full Time Benefits ~ Rate at $16.00 / hour ~ PTO 80 hours of vacation, 40 hours of sick (roll-over...