Pharmacovigilance Specialist Job at Planet Group, Remote

NHF1bXpRWWJWRjYzTkF2cUhiNGZQckVsNEE9PQ==
  • 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

Swift Refrigerated

Dedicated Class A CDL Truck Driver - Home Weekly! Job at Swift Refrigerated

 ...and Prescription Drug Plans~Disability, Life, and Critical Illness CoverageSWIFT DEDICATED REFRIGERATED FLEETA Class A Driving Career for a LifetimeREQUIREMENTS:~CDL (A) required, No experience necessary, Will train~Subject to background screening.... 

Cornerstone Gigs

Mobile Game Beta Tester Job at Cornerstone Gigs

 ...Job Title: Mobile Game Beta Tester Location: Remote (Global) Job Overview: We are seeking a highly motivated and detail-oriented individual to join our remote QA team as a Mobile Game Beta Tester . In this role, you'll be responsible for playing and rigorously... 

Gigs

Medical Assistant - Maternal Fetal Medicine Job at Gigs

 ...224 clinic locations and 46 medical centers, Sanford Health is one...  ...family values! People enjoy working here and it shows. Monday...  ...responsible, and empathetic Medical Assistant (MA/CMA) who will be involved...  ...to maintain a healthy home-work balance. For more information... 

EVONA

Aerospace Engineer Job at EVONA

 ...imaging schedules and system readiness checks Collaborate with engineering teams in anomaly investigations and assist in data collection...  ...Required: Bachelors degree in a STEM discipline such as Aerospace Engineering, Mechanical Engineering, Electrical Engineering,... 

Clinical Staffing Resources

CNA Opportunities in Long-Term Care - Per Diem Shifts Available! Job at Clinical Staffing Resources

 ...per diem LTC Certified Nursing Assistants (CNA) Licensed Practical Nurses (LPN)...  ...Nurses (RN) to work in one of our long-term care facilities in Bronx, NY and the Surrounding...  ...Must have current experience in Nursing Home / Long Term Care \n Must have current State...