Pharmacovigilance Specialist Job at Planet Group, Remote

L0RnVmpDWkpSS2lFb21UVC9QaVlERjNJSGc9PQ==
  • 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

Intuit

Business Tax Preparer - Work From Home Job at Intuit

Join to apply for the Business Tax Preparer - Work From Home role at Intuit1 day ago Be among the first 25 applicantsJoin to...  ...comparisons across categories of ethnicity and gender.Seniority level Seniority level Entry levelEmployment type Employment type Full-timeJob... 

CHI

Hospital Chaplain: On-Call Spiritual Care & Crises Support Job at CHI

A health care facility in Dickinson, ND is seeking a Chaplain to provide spiritual support and crisis intervention for patients and families. This position requires relevant educational qualifications and experience, specifically in healthcare settings. Ideal candidates... 

NoGigiddy

Chat Support Agent (Remote) - Entry Level, No Degree Required - 15 - 18 per Hour Job at NoGigiddy

About NoGigiddy: NoGigiddy is a premier on-demand staffing app that connects gig workers with flexible job opportunities across various industries. Our platform specializes in offering work that fits your schedule, providing you with the flexibility and convenience...

Koalafi

Manager of Business Analysis (Valuations & Forecasting) Job at Koalafi

 ...You'll Do We're seeking a hands-on and analytically strong Valuations and Forecasting Lead to develop and manage our lease portfolio...  ...payments, cash flows, and charge-offs under multiple economic and business scenarios. Lead loss forecasting efforts by designing... 

Ecumenical Techno Consultancy Services (eTCS)

Mobile App Developer Job at Ecumenical Techno Consultancy Services (eTCS)

We are looking for Mobile App Developer, who is passionate about developing interactive mobile applications for Android and iOS by using latest technologies.Should be highly organized and able to manage workload.Should be good in verbal and written communication skills...