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

luckyscent

Graphic Designer Job at luckyscent

About Us Since 2002, Luckyscent has been the playground for perfume lovers who refuse to smell like everyone else. We scout the globe for niche, rare, rule-breaking fragrances and bring them to our community through our online store and our boutiques in NYC, Hollywood...

Fromm

Automation Manager Job at Fromm

Are you ready to drive innovation and lead a high-performing team? Fromm Electric Supply is offering an exciting opportunity for a strategic and dynamic Automation Manager to spearhead our Rockwell Automation sales initiatives, elevate technical excellence, and inspire...

Fifth Group Restaurants

Sous Chef Job at Fifth Group Restaurants

 ...Sous Chef Who you are: You are a master of organization and efficiency, running shifts with seamless precision. Your unwavering...  ...our purpose is to ignite passion and bring joy to people's lives? Since our establishment in 1993, we have been dedicated to making... 

Contractors Electrical Distributors

Lighting Quotations Specialist Job at Contractors Electrical Distributors

 ...continuous improvement processes and represent top manufacturers in each market area. Our services include switch-gear sales support, lighting project management, audits, and inventory management for streamlined operations. Role Description Lighting Quotations... 

Exos

Performance Coach Job at Exos

 ...Job Summary: Join our dynamic team as a Performance Coach in a corporate fitness center setting! We are dedicated to helping our clients achieve their health and wellness goals through customized fitness programs, engaging group classes, and one-on-one training. If...