Senior Pharmacovigilance Specialist

The Senior Pharmacovigilance Specialist works closely with the Area Safety Representative (ASR) and Global Patient Safety (GPS) and Regional PV Team to ensure compliance with local regulations corporate standards and risk management obligations in an assigned Therapeutic Area. You will monitor and communicate local safety information lead cross-functional safety education initiatives and manage risk minimisation activities including the assessment and implementation of Risk Management Plans safety agreements and periodic safety reporting requirements. With a strong ability to build partnerships across Medical Affairs Regulatory Affairs and Brand Teams this role plays a critical part in embedding a proactive safety culture and ensuring the highest standards of patient safety at the affiliate level.

KEY DUTIES AND RESPONSIBILITIES

• Collaborates with the Regional PV Team to support the ASR in ensuring oversight of all aspects of the performance and functioning of the PV system in compliance with local regulations internal company timelines/standards.
• Develop a deep knowledge of the Therapy Area including disease and product knowledge safety profile benefit risk information and competitor landscape.
• Effectively communicate safety information to stakeholders to positively impact educational strategies and business strategies such as launch excellence patient experience and emerging safety information.
• Through local safety monitoring detect opportunities that add value to the understanding of the use of Abbvie products. Performs surveillance of Local Safety Information and communicates to Affiliate Medical Director (AMD) and Global Patient Safety (GPS) for escalation and evaluation.
• Reviews summary reports of local research-related activities and communicates any safety insights/findings with Medical Teams and GPS.
• Leads product safety communication and education initiatives for local cross-functional teams on major PV topics and on local data sources
• Build strong partnerships and work collaboratively with stakeholders and other functions across the business such as Regulatory Affairs Medical Affairs Brand Teams as applicable
• Maintains awareness of and input into safetyrelated product enquiries/issues received from external stakeholders/vendors working with Medical Affairs Regulatory Affairs Affiliate Product Leads (APLs) and the Product Safety Teams (PSTs) as required..
• Supports the ASR in setting a solid local safety & PV strategy incorporating proactive PV contributions to ensure a successful product / indication launch at the affiliate and in the local risk management activities for an assigned Therapeutic Area and Product in alignment with local regulations with the Affiliate Medical Director (AMD).
• Develops a deep knowledge of the RMPs (Risk Management Plans) of products and coordinates the receipt and distribution of RMPs Core Implementation Strategy (CIS) and additional risk minimization measures (aRMM) to relevant affiliate stakeholders.
• Liaises with the affiliate stakeholders and Office of Risk Management and where applicable seek involvement of relevant global stakeholders during development or revision of the Australian Specific Annex Local Implementation Strategy (LIS) & local aRMM.
• Performs the assessment and implementation of the CIS and accompanying aRMM when applicable
• Collaborates with GPS Regional PV Teams to ensure the monitoring of local (and applicable regional/area) PVrelevant hard intelligence leading the impact assessment of them.
• Supports the ASR in PV advocacy efforts in alignment with the AbbVie GPS and QPPV Office advocacy guidance.
• Supports the ASR and GPS Regional PV Team to ensure quality system mechanisms are in place including:
• Development and maintenance of local procedures in line with corporate procedures and local requirements.
• Impact assessment of new/updated corporate policies process and procedures.
• Local PV Exception Reporting/CAPA process.
• Business continuity plan and testing.
• Supports the ASR and GPS Regional PV Team in managing internal PV audits audits of affiliate service providers/third parties and Regulatory Authority PV Inspections.
• Supports GPS Regional PV Teams in the development of CAPA in response to observations and the tracking actions to completion in a timely manner.
• Supports the ASR and GPS Regional PV Team to ensure Adverse Event reporting Periodic Safety Reporting requirements are in place including:
• Ensuring reporting of both clinical and postmarketing Individual Case Safety Reports (ICSRs) and Periodic and Aggregate Reports to the Regulatory Agency
• Ethics Committees and Investigators to comply with corporate PV procedures and with local and regional PV regulations as required.
• Reviewing periodic safety update reports (PSURs/DSURs) for a determined TA or product to obtain information on the risk/benefit profile of products and share with the local affiliate stakeholders.
• Partners with GPS Regional PV Team to ensure the preparation of periodic safety reports (e.g. PSUR).
• Ensures submission of periodic & aggregate safety reports and ensures documentation of evidence
• Supports the ASR and GPS Regional PV Team in ensuring overall training compliance with corporate procedures and local PV requirements including the maintenance of the PV Training Matrix and the development of additional PV training materials as required.
• Acts as key safety advisor for affiliate crossfunctional partners on safety topics ensuring that business partnerships involving activities where there is a reasonable possibility for the identification and/or handling of safety information are assessed for the generation of safety information and the applicable PV requirements and that applicable PV and safety data exchange agreements (SDEAs) are implemented.
• All sources of adverse events and other safety information are identified at the local level and mechanisms are in place for collection and collation of all data by GPS Regional PV Team.
• Content of local Safety Data Exchange Agreements (SDEAs) and other PV agreements conforms to AbbVie procedures and local requirements and maintains the inventory in the GPS PV Agreements Database.
• Compliance with local agreements
• Supports the ASR and the Regional PV Team to ensure that a Local Affiliate PV Disaster Recovery Plan/Business Continuity Plan is established in a riskbased manner to allow for continuation of critical business processes for PV.
• Ensures oversight & management of safety reporting responsibilities in medical affairs activities including Safety Review Plan and ongoing monitoring
• Review clinical study/medical research protocols and investigator contracts/agreements to ensure compliance with PV Obligations and document appropriately.
• Report any adverse event within 24 hours as per AbbVies policies and procedures.
• Proactively participate in AbbVies WHS programs adhere to policies and promote a safe work environment at all times.
• Adhere to AbbVies internal codes of conduct and compliance processes.
• Other ad hoc duties such as administrative duties as requested.

Qualifications :

• Medical pharmacy or life-sciences degree (or equivalent).
• Minimum 2 years at Senior Associate level with a good understanding across the entire PV system
• Experience working in the pharmaceutical industry in Pharmacovigilance Clinical Development Medical Affairs or Regulatory Affairs role.
• Good understanding of medical concepts and demonstrated strategic thinking understanding of business priorities and Integrated Brand Plan strategy
• Resilience despite obstacles uncertainty and ambiguity
• Having a global mindset: cultivate cross-cultural cross-geographical collaboration
• Work cross functionally and foster strong partnerships
• Ability to communicate information accurately and can work effectively as a member of the PV team and broader medical department
• Focused on compliance; identifies manages and escalates issues in a timely manner
• Demonstrated ability to take the initiative and challenge the status quo
• Demonstrated attention to detail and prioritisation
• Excellent written and spoken communication and presentation skills
• Fluency in written and oral English to facilitate communications with GPS regional Medical other global functions and Health Authorities
• Demonstrated understanding of Australian and New Zealand Pharmacovigilance and related regulations.
• Knowledge of understanding and interrogating safety data.
• Good understanding of healthcare environment and regulatory framework for AU and NZ.
• Management of Benefit Risk activities.

Flexibility and Availability: In line with Australias Right to Disconnect legislation we recognise and respect employees right to refuse contact outside of their working hours unless such refusal is deemed unreasonable. As we operate in an international matrixed environment there may be occasions where your role requires participation in business meetings outside of standard hours. We value and support flexibility and appreciate your willingness to occasionally accommodate these requests to ensure effective collaboration and communication within our global team.

Additional Information :

AbbVie is an equal opportunity employer and dedicated to fostering an inclusive flexible and supportive workplace that values and respects every individual. We are committed to operating with integrity driving innovation transforming lives and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability. We ensure a fair and inclusive recruitment process without discrimination against any employee or applicant because of and not limited to race religion age physical or mental disability gender identity or expression sexual orientation or marital status. Our hiring process is flexible and accessible so if you have any specific requests or accessibility requirement please feel comfortable to let our team know by emailing or speaking with your Recruiter and well make any necessary adjustments to accommodate your needs.

WAYS WE WORK

• All For One Abbvie; We weigh all decisions against the common good. We inspire share and create as a team. We solve problems for all rather than serving our immediate team.
• Decide Smart & Sure; We make intelligent decisions to create the best outcomes. We act quickly embrace experimentation and learn what doesnt work and get on to what does.
• Agile & Accountable; We streamline and eliminate unnecessary obstacles. We plan but adapt as we go. We delegate and make tough decisions to ensure focus on results staying keenly aware of the urgency in all we do.
• Clear & Courageous; Open honest candid dialogue is core to our work and how we act with each other. We share information freely and continuously to find solutions. We admit mistakes. We grow stronger by putting the courage of our conviction to the test.
• Make Possibilities Real; We question with endless curiosity. Were never satisfied with good enoughpatients depend on us to deliver more. We challenge ourselves to find creative constructive solutions to turn possibilities into reality.

CODE OF CONDUCT & BUSINESS INTEGRITY STATEMENT

• AbbVie is committed to observing high integrity and ethical standards in all its business dealings with our customers with each other business partners and suppliers.
• AbbVie as a responsible corporate citizen will adhere to these standards as well as to local national and international laws.
• All AbbVie employees are responsible for maintaining the Companys reputation for conduct in accordance with the highest level of business integrity ethics and compliance with the law.
• Soliciting and/or accepting/attempting/offering bribes or any illegal gratification is therefore cause for immediate dismissal.
• AbbVie is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion.

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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Work :

No

Employment Type :

Full-time

Experience: years
Vacancy: 1