Pharmacovigilance Associate

Regulatory Affairs/Clinical Affairs Belrose, NSW Balcatta, WA


Description

Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold.  Help us do it.

Manage the pharmacovigilance systems for Perrigo in Australia and New Zealand. This is a broad role covering all aspects of pharmacovigilance working closely with Perrigo corporate functions in Europe and the United States. The incumbent must ensure the company is represented in a professional and ethical manner at all times. Perrigo offers flexible work practices, after orientation and training a portion of this role can be home based work.

Main Duties

  • Acts as qualified person responsible (QPPVA) for PhV according to TGA and Medsafe requirements
  • Maintain pharmacovigilance quality systems within the company’s overall quality system framework.
  • Ensure all data is generated and maintained in accordance with record integrity and privacy requirements.
  • Oversee contract negotiations with distribution partners and vendors.
  • Conduct case processing and reporting.
  • Determine the need for case follow up and perform as appropriate.
  • Liaise with key local partners and corporate functions regarding safety data collection and data reconciliation.
  • Local and global literature searches.
  • Signal Management
  • Review FAQ’s, abbreviated product information and other medical information documents.
  • Subject matter expert representative for internal and external audits.
  • Act as primary point of contact with TGA and Medsafe.
  • Develop and maintain expertise on applicable corporate and local regulations for pharmacovigilance.
  • As medical information delegate co-ordinate and administer drug information services by providing technical/medical information to doctors, pharmacists, other healthcare professionals and consumers.

Skills & Experience

  • University Degree Qualification in health (Pharmacy/Nursing/Medicine) or equivalent required or equivalent experience preferred.
  • A minimum of three (3) years’ experience in pharmacovigilance.
  • Previous experience interacting with the public. Proven ability to handle sensitive situations appropriately.
  • Ability to work under pressure with minimal supervision and deal effectively with confidential information.
  • The ability to create meaningful relationships with a broad range of people.
  • Proficient in Microsoft Excel, Word, Power Point and ability to learn new software applications.
  • Experience in searching for scientific information with critical and thorough appraisal of the scientific literature.
  • Exceptional communication with the ability to effectively communicate medical and scientific information to audiences with varying medical/scientific understanding.
  • Fluency in spoken and written English.
  • Full Australian Working rights

We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.