Manager Local Pharmacovigilance (New South Wales)

Manager Local Pharmacovigilance (New South Wales)

05 Aug
|
Cencora
|
New South Wales

05 Aug

Cencora

New South Wales

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!
Summary:Responsible for the planning and execution of operational tasks and all aspects of technical delivery and project management in the field of PharmacovigilanceManage pharmacovigilance activities according to Local Operating Company/Cluster requirements in OceaniaAct as the Pharmacovigilance Country Lead/Deputy of the Pharmacovigilance Country Lead concerning all Pharmacovigilance activitiesAct as National Contact Point or Qualified Pharmacovigilance Professional in Australia & New ZealandCollaborate with internal/external key partners, where applicableResponsibilities:Ensure compliance with all applicable Global and local Pharmacovigilance processes and regulationsMaintain a constant state of audit and inspection readinessSupport the development and implementation of processes, systems, and tools to manage local Pharmacovigilance activitiesWriting/Review of procedural documents such as Working Instructions, Standard Operating Procedures, Working Procedures, Templates etc. for PharmaLex Pharmacovigilance projectsPerform 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 areasMonitor 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 initiationReview Pharmacovigilance Intelligence Reports and perform gap analyses/impact assessments for local applicabilityDeliver 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 communicationProvide 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 trainingAct as a mentor to colleagues new in their roles or new in various projects/tasksClient management and proactively identify and recommend improvements to enhance service quality for clientsSupport the initiation and closure of deviations and Corrective and Preventive Actions, as applicableThe 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 projectsStrong stakeholders' managementMinimum of 5 years' advanced experience in pharmacovigilance or related environments, with adjustments based on country/regional requirementsAdvanced experience of working cross-functionally, preferably in Research & Development companiesExcellent knowledge of Pharmacovigilance regulations for the post-marketing global environment and applicable legislationExecute positive documentation practices with accuracy and attention to detailsOur 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 DetailsSummary:Responsible for the planning and execution of operational tasks and all aspects of technical delivery and project management in the field of PharmacovigilanceManage pharmacovigilance activities according to Local Operating Company/Cluster requirements in OceaniaAct as the Pharmacovigilance Country Lead/Deputy of the Pharmacovigilance Country Lead concerning all Pharmacovigilance activitiesAct as National Contact Point or Qualified Pharmacovigilance Professional in Australia & New ZealandCollaborate with internal/external key partners, where applicableResponsibilities:Ensure compliance with all applicable Global and local Pharmacovigilance processes and regulationsMaintain a constant state of audit and inspection readinessSupport the development and implementation of processes, systems, and tools to manage local Pharmacovigilance activitiesWriting/Review of procedural documents such as Working Instructions, Standard Operating Procedures, Working Procedures, Templates etc. for PharmaLex Pharmacovigilance projectsPerform 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 areasMonitor 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 initiationReview Pharmacovigilance Intelligence Reports and perform gap analyses/impact assessments for local applicabilityDeliver 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 communicationProvide 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 trainingAct as a mentor to colleagues new in their roles or new in various projects/tasksClient management and proactively identify and recommend improvements to enhance service quality for clientsSupport the initiation and closure of deviations and Corrective and Preventive Actions, as applicableThe 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 projectsStrong stakeholders' managementMinimum of 5 years' advanced experience in pharmacovigilance or related environments, with adjustments based on country/regional requirementsAdvanced experience of working cross-functionally, preferably in Research & Development companiesExcellent knowledge of Pharmacovigilance regulations for the post-marketing global environment and applicable legislationExecute good documentation practices with accuracy and attention to detailsWhat Cencora offersBenefit 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 timeAffiliated CompaniesAffiliated Companies: PharmaLex AustraliaEqual Employment OpportunityCencora 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 ************ or email ******.
We will make accommodation determinations on a request-by-request basis.
Messages and emails regarding anything other than accommodations requests will not be returnedBe careful - Don't provide your bank or credit card details when applying for jobs.
Don't transfer any money or complete suspicious online surveys.
If you see something suspicious, report this job ad .
Sign in to start saving jobs in your profile.Don't have a Jora account?
Register with:Do you want to receive recommendations for similar jobs?
By creating an email alert, I agree to Jora's Terms and Privacy Policy and can unsubscribe anytime.
#J-*****-Ljbffr

📌 Manager Local Pharmacovigilance (New South Wales)
🏢 Cencora
📍 New South Wales

Reply to this offer

Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.

Subscribe to this job alert:

Get the latest job offers by email for: manager local pharmacovigilance (new south wales) / new south wales

Subscribe to this job alert:

Get the latest job offers by email for: manager local pharmacovigilance (new south wales) / new south wales