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Pharmacovigilance (Pv) Country Lead (18 Month

4 months ago

Sydney, New South Wales, Australia Takeda Pharmaceutical Full time

Are you looking to join an organisation with a strong purpose and great culture? At Takeda, we strive towards Better Health for People and a Brighter Future for the World through leading innovation in medicine in our four core therapy areas of Oncology, Gastroenterology, Rare Diseases and Neuroscience, plus Plasma-Derived Therapies and Vaccines.


Takeda Oceania has been certified as a Top Employer for 7 consecutive years, the most of any current life sciences organisation in Australia, for our consistent investment in our people and culture.

Here you will not only work with friendly people, but you can expect to grow in your career, have flexibility and be celebrated for who you are.


About the opportunity:

We are seeking a highly motivated and experienced Pharmacovigilance (PV) Country Lead to join a strong and dynamic team.

This is an 18-month contract opportunity which has been created due to long service leave, increasing operational workload and expanded responsibilities of the PV Area / Cluster Lead.

This is a great opportunity to build your pharmacovigilance career as a PV Country Lead.

You will be responsible for providing PV support and functional expertise within the Local Operating Company (LOC) in Australia and New Zealand.

You will ensure compliance to applicable local legislation, company standards and procedures. And in partnership with the team, you will define and implement local PV strategies.

A typical day will involve:

  • Managing and overseeing the PV system in Australia and New Zealand, in accordance with local legislation and company requirements. This may include conducting safety reporting and submissions, business continuity, trainings, PV agreements and obligations, risk management plan implementations, crossfunctional engagements, organised data collection programs, PV vendor/supplier oversight and management.
  • Working closely with the PV Area / Cluster Lead, Patient Safety Lead and regional vendors to support and facilitate LOC PV interactions.
  • Maintaining an appropriate stakeholder network to facilitate and implement Global Patient Safety Evaluation (GPSE) strategies, in collaboration with the PV Area / Cluster Lead.

Desired qualifications and experience:

  • A life sciences / health professions degree
  • Bachelor's required; advanced degree highly desirable.
  • Relevant pharmaceutical or healthcare related industry experience.
  • Advanced experience in PVrelated environments at local, regional and / or global levels.
  • Excellent knowledge of PV regulations for the postmarketing global environment and applicable legislation.
  • Ability to deal with decisionmaking and problemsolving processes in complex organisations, and generate collaboration and followership.
  • A high level of accuracy and attention to detail.
  • A flexible mindset and one of curiosity, that embraces lifelong learning.
  • Effective leadership and partnership skills with stakeholders, both internally and externally.

Flexible benefits we think you'll love:

  • Competitive and equitable remuneration for all.
  • We value a flexible and hybrid working environment and encourage our employees to work in ways that meet their life/work commitments and support their unique wellbeing needs.
  • Additional paid leave at the end of the year to take a step back and relax however you choose.
  • Variety of innovative wellbeing initiatives and access to the awardwinning Thrive platform.
  • Equal parental leave. We offer an inclusive framework of 12 weeks of equal paid leave to support new parents.
  • Social connection. We offer regular formal and informal events for the team to connect and unwind.
  • Every employee has access to our Employee Assistance Program which includes emotional, legal and financial support for themselves as well as their families. We are a Mental Health First Aid Recognised Skilled Workplace.
If you require accessibility assistance at any stage of the recruitment or interview process, please advise us.

We look forward to hearing from you

Applications close:
Friday, 14th July 2023

Locations:

Sydney, Australia

Worker Type:

Employee

Worker Sub-Type:

Fixed Term (Fixed Term)

Time Type:

Full time