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Manager Local Pharmacovigilance

Cencora -
North Sydney NSW

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Job Details

Full-time

Qualifications

Management
Research
Education
Bachelor's degree

Full Job Description

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

Summary:

Responsible for the planning and execution of operational tasks and all aspects of technical delivery and project management in the field of Pharmacovigilance
Manage pharmacovigilance activities according to Local Operating Company/Cluster requirements in Oceania
Act as the Pharmacovigilance Country Lead/Deputy of the Pharmacovigilance Country Lead concerning all Pharmacovigilance activities
Act as National Contact Point or Qualified Pharmacovigilance Professional in Australia & New Zealand
Collaborate with internal/external key partners, where applicable

Responsibilities:

Ensure compliance with all applicable Global and local Pharmacovigilance processes and regulations
Maintain a constant state of audit and inspection readiness
Support the development and implementation of processes, systems, and tools to manage local Pharmacovigilance activities
Writing/Review of procedural documents such as Working Instructions, Standard Operating Procedures, Working Procedures, Templates etc. for PharmaLex Pharmacovigilance projects
Perform comprehensive safety surveillance and end‑to‑end case management activities, including Adverse Event and Product Quality Complaint handling, follow‑up, Individual Case Safety Report data entry and Quality Control, expedited reporting, mailbox monitoring, reconciliations, preparation of Additional Risk Minimisation Measure/Direct Healthcare Professional Communication materials, completion of metrics/Key Performance Indicators, and provision of pharmaceutical expertise across Special Consulting Services/Local Pharmacovigilance Affiliate Services practice areas
Monitor local Risk Management Plans and risk‑minimization measures, oversee Market Research and Patient Support Programs to ensure correct handling of safety data, and review local study protocols to define compliant PV processes prior to study initiation
Review Pharmacovigilance Intelligence Reports and perform gap analyses/impact assessments for local applicability
Deliver Pharmacovigilance and client‑specific training(s)
Serve as Pharmacovigilance Country Lead/Qualified Pharmacovigilance Professional or designated backup for Oceania while engaging with internal stakeholders (Medical, Regulatory, Quality Assurance, Commercial) and external stakeholders (vendors, partners) to fulfil Pharmacovigilance obligations and manage all Pharmacovigilance‑focused communication
Provide program management support across Pharmacovigilance projects, maintain oversight of project resource needs, escalate requirements to line management, and perform cross‑functional tasks across service lines or project management activities in alignment with skills and training
Act as a mentor to colleagues new in their roles or new in various projects/tasks
Client management and proactively identify and recommend improvements to enhance service quality for clients
Support the initiation and closure of deviations and Corrective and Preventive Actions, as applicable
The employee agrees to take over primary listed tasks and responsibilities in other service lines, project management activities as client contact point and additional reasonable tasks that align with their abilities, qualification and training, if required

Education:

Health professional or life sciences degree (Bachelor’s required; advanced degree preferred)

Experience:

Someone who is a Pharmacovigilance (end-to-end) person and a Qualified Pharmacovigilance Professional or a deputy Qualified Pharmacovigilance Professional managing global projects
Strong stakeholders' management
Minimum of 5 years' advanced experience in pharmacovigilance or related environments, with adjustments based on country/regional requirements
Advanced experience of working cross-functionally, preferably in Research & Development companies
Excellent knowledge of Pharmacovigilance regulations for the post-marketing global environment and applicable legislation
Execute good documentation practices with accuracy and attention to details

What Cencora offers

Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Full time

Affiliated Companies

Affiliated Companies: PharmaLex Australia

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [email protected]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

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Refine Your Search

regulatory implementation & reporting manager jobs in parramatta, nsw

Manager Local Pharmacovigilance

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