Valeant Pharmaceuticals

Manager, Global Pharmacovigilance & Risk Mgmt (Aggregate Reporting)

US-FL-Tampa
Job ID
9266
Category
R&D
Pos. Type
Full Time

Overview

- Preparation, distribution, and quality review of Aggregate reports
- Oversight of vendor(s) for aggregate reports writing
- Submission of Aggregate reports in collaboration with Regulatory Affairs
- Provide training on aggregate reports or for other departments on pharmacovigilance related aspects
- Provide coordination and support for the internal Pharmacovigilance activities within Valeant Pharmaceuticals International
- Provide support in establishing/maintaining PV system

Responsibilities

- Responsible for preparation of Aggregate reports

  • Prepare Aggregate reports according to the applicable legal requirements
  • Acquire data necessary for Aggregate reports preparation
  • Prepare or review Summary Tabulations and Line listings
  • Organize scientific literature review for Aggregate reports
  • Present all available relevant safety data
  • Review Aggregate reports prepared by Vendor(s)
  • Prepare cover letters and all relevant documents for submission if needed
  • Keep Global Periodic Report schedule up to date
  • Participate in aggregate reports planning and submission tracking
  • Archive all source data and relevant files in the defined way
  • Answer to competent authorities requests
  • Participate to follow-up of new Regulatory requirements related to aggregate reports
  • Review Aggregate Reports sections of Safety Data Exchange Agreements
  • Participate to audits and PV inspections

- Provide training on aggregate reports or for other departments on pharmacovigilance related aspects as required

  • Initial training for new employees if requested
  • Periodic training for other departments if requested

- Maintain the whole internal and external correspondence coming within her duties and activities and ensures relevant archiving of PV documentation if needed

- Participate in creation and implementation of Pharmacovigilance SOPs if needed

Other:

  • Must understand and apply all company SOPs, policies and procedures
  • Take care of a good company reputation within his / her positive attitude
  • Undertakes to comply with the regulatory requirements applicable to the pharmaceutical activities that he/she works on

 

Qualifications

- University degree with Pharmaceutical/Medical/Scientific background

- Proven oral and written communication skills

- Languages: excellent English skills

- Technical knowledge of job related systems

- Understanding of International Pharmacovigilance regulations including GVP, GMP and ISO requirements

- Computing skills: user requiring advanced literacy (Microsoft Office applications, Adobe Acrobat, Safety database)

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