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15

April

Product Safety Manager

ON Q RECRUITMENT - North Sydney, NSW

Any Industry
Source: uWorkin

JOB DESCRIPTION

Our client is a successful, complementary medicines company with diverse brands of well known household products. Due to continued growth, they have a newly created role for a Product Safety Manager to conduct all level of product safety requirements.

Your role will include clinical assessments and investigations, implementing and maintaining product safety standards and procedures, and the monitoring and reporting of product safety for the organisation. You will enjoy having the reigns to shape the role and strategically refine all safety-related activities across business.

This role will suit someone with a high level of initiative who is seeking the next step in their career and wants to "own" the PV function. Sitting within the Scientific Affairs team, you will have the opportunity to take on some Regulatory and NPD activities to further expand your skill set.

Specific Responsibilities:

  • Performs all necessary duties of the Qualified person responsible for pharmacovigilance (PV) in Australia (QPPVA) ensuring the organisation has an effective pharmacovigilance system in place and complies with the legal pharmacovigilance requirements
  • Coordinates and manages the safety signals and implementation of risk minimisation activities
  • Drafts, clinically assesses, implements and maintains ingredient and product safety assessments
  • Respond to internal and external stakeholder medical enquiries related to product safety with a consumer/patient centric focus to ensure compliance and appropriate product development and labelling
  • Provides product safety systems training to employees & relevant 3rd parties
  • Responsible for vendor management related to product safety, particularly where safety data collected interfaces with allergen requirements
  • Implements CAPAs for any identified process and/or safety risk(s)

Qualifications and Experience:

  • Minimum tertiary education in pharmaceutical or related life science, preferably in a qualified healthcare professional field
  • Relevant experience working in the Australian product safety and pharmacovigilance environment responsible for clinical assessments
  • Excellent working knowledge of the regulatory requirements for managing and reporting adverse events in Australia, and an understanding of applicable global PV requirements
  • Comprehensive understanding of medical terminology, clinical assessment and case writing, as well as understanding of scientific literature
  • Highly developed attention to detail and service, communication, organisational, and problem-solving skills
  • Practical experience in safety databases, SOP writing and document management.

Personal Characteristics:

  • A self-starter with have a hands-on approach and a strong "can-do" attitude.
  • Ability to work independently and be self-motivated.
  • Results oriented, entrepreneurial, and self-motivating with an innate drive to meet and exceed targets
  • Possess a high level of business ethics, integrity and professionalism, and the ability to ensure those standards are reflected in the business dealings.
  • Able to build strong working relationships internally and externally
  • An ambition to transform to a leadership position

Benefits:

  • Subsidised health insurance
  • Onsite gym
  • Onsite barista, free coffee and smoothies (soups in the winter)
  • Monthly product allowance
  • Free onsite parking

This is a full time permanent role with a reputable, fast paced and decisive company. Coming into a newly created role you will have the scope to build and shape how it grows and how you grow within the company. For the right candidate, a part time arrangement can be considered at 4 days per week.

Please note this role will be mostly office based and in the Northern Beaches.

If you are interested in taking the next step in your career, follow the directions below to apply or call On Q Recruitment on 02 9431 2555 for a confidential discussion.

Please send your Cover Letter and Resume in Word Doc Format (no text boxes or tables please) and follow the Apply Links. Visit onqrecruitment.com.au to review all our current vacancies.