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

The Hair Shop

Warehouse Manager Job at The Hair Shop

 ...Position Summary As Warehouse Manager you are responsible for all fulfillment, logistics and receiving activities of the warehouse. You will ensure that all orders are fulfilled accurately and timely to meet The Hair Shop quality standards. The warehouse manager... 

ABC Auto Repair and Transmissions

Automotive Technician B+ Level - ABC Auto Repair & Transmission Job at ABC Auto Repair and Transmissions

 ...a Automotive Technician with a passion for cars and a dedication to providing excellent service? Become part of our dynamic team at ABC Auto Repair and Transmission. We Pride Ourselves on Delivering Top Notch Automotive Service to our Valued Customers. We have a Strong... 

Piedmont

Primary Care- Nurse Practitioner/ Physician Assistant- Augusta Job at Piedmont

 ...currently employed at Piedmont Healthcare, please click the Current Employee button above to submit your application. Primary Care- Nurse Practitioner/ Physician Assistant- Augusta Description Advanced Practice Practitioner - Primary Care Outpatient Piedmont... 

Amazon.com Services LLC - A57

2026 MBA Business Developer Summer Intern, Corporate Business Development (CorpBD) Job at Amazon.com Services LLC - A57

 ...individual to join the Corporate Business Development group. CorpBD is part of a centralized...  ...will need to work collaboratively with internal management teams to understand where...  ...hours/week minimum and commit to a 12 week internship maximum - 5+ years of relevant... 

MUFG Capital Analytics

Financial Reporting Analyst Job at MUFG Capital Analytics

 ..., diversity, and flexibility! Job Description This entry-level position will have the primary responsibility of analyzing the...  ...Requirements Education College graduate with a business degree Minimum of 9 accounting hours and 3 finance hours Preference...