Pharmacovigilance Specialist Job at Planet Group, Remote

N25UY2lnMWRoS3J1eWhDOFRhL1A2Ull2MFE9PQ==
  • Planet Group
  • Remote

Job Description

Summary:

  • Provides operational support for global pharmacovigilance activities of marketed products.
  • Ensures pharmacovigilance deliverables are of the highest quality and meet global regulatory reporting timelines.
  • Responsible for data review, compilation, and analysis, including management of the integrated safety database.
Primary responsibilities for the role:
  • Management of Adverse Events including activities such as processing adverse event case reports and conducts follow-up .
  • Notifies regulatory agencies and business partners accordingly; responds to requests from regulatory agencies .
  • Reviews scientific literature and bibliographic sources; draft and manage periodic safety update reports.
  • Evaluates safety profiles; draft and manage signal detection reports; ensures document filing and archiving.
  • Participation in the processes of involving the collection, processing, review and distribution of adverse event information regarding development and marketed pharmaceutical products.
  • Contributes to ensure compliance of pharmacovigilance activities including activities such as conduct case reconciliation with concerned departments, affiliates, distributors or business partners
  • Take part in self-inspection visits, audits, inspections and in CAPAs management, create or update pharmacovigilance procedures and working practices
  • Provide training to concerned persons based on the training plan and managing training documentation; archive documents according to prevailing standards
  • Support in the procedures of global pharmacovigilance operations such as Standard Operation Procedures (SOPs), internal business practices or working instructions.
  • Serves in an advisory capacity including activities such as product monographs review, draft responses to pharmacovigilance requests from regulatory agencies; participates in the drafting and implementation of pharmacovigilance contracts and agreements.

Pay Rate Range: $30-50/hr depending on experience 

Job Tags

Remote job, Contract work,

Similar Jobs

Ariat International

Footwear Design Intern Job at Ariat International

 ...the Role Ariat is seeking a motivated and creative Footwear Design Intern to join our innovative Footwear Design team. This internship...  ...design while contributing to the evolution of industry-leading products. The intern will collaborate closely with seasoned designers... 

Opti Staffing Group

Lumber Mill Millwright Job at Opti Staffing Group

OPTI STAFFING IS HIRING! Location: North Plains, Oregon Compensation: DOE Hours: Monday - Friday, 7-3:30pm Who We Are: A Lumber manufacturing company that has evolved from humble beginnings as a small manufacturer of clear Douglas Fir products to a leading...

BlackRock Resources LLC

Construction & Commissioning Scheduler Job at BlackRock Resources LLC

 ...Full-time | On-site presence required Industry: Industrial/Power/Data Center Construction Were looking for an experienced Construction...  ..., and integration with project systems like Excel, Power BI, or CMMS tools. If you thrive in a fast-paced, collaborative... 

Bushnell Performance Optics

Mechanical Engineer, Optics Job at Bushnell Performance Optics

 ...The Engineer II -Optics is a key contributor to the Optics product creation team and will be tasked with leading finished good engineering for various product classes, including but not limited to connected cameras, binoculars, rifle scopes, & laser range finders. The... 

the Global Times

Copy Editors Job at the Global Times

Chinas leading English-language daily newspaper, the Global Times, is seeking experienced, enthusiastic and driven copy-editors to join its growing team.Do you have an eye for speling mistakes? Do split infinitives make you want to literally scream? Hopefully, hanging...