Hi Crispy The conclusions above were derived from my research...

Hi Crispy

The conclusions above were derived from my research into the role of Patient Safety (Pharmacovigilance) Partners and their relationship with partnerships in the biotech industry.

The position was on Roche's Linkedin page

https://www.linkedin.com/jobs/view/3942191092

Patient Safety (Pharmacovigilance) Partner Melbourne, Victoria, Australia · 1 week ago

· 82 applicants·
Biotechnology Research.
About the job

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care.

Join Roche, where every voice matters.The Position A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.
A patient-safety focused role for Pharmacovigilance professionals
A diverse and supportive team Agile way of working in a fully flexible work environment
A Patient Safety Partner delivers expert knowledge on the safety profiles of Roche medicines, defines how to manage risks to patients, and coordinates the pharmacovigilance (PV) system activities for the company.
The Patient Safety Partner is an expert on the safety profile of Roche products and oversees PV processes ensuring they fit for purpose and acts as subject matter expert for PV processes.

Key responsibilities include but not limited to:

- Develops strategy, informs and trains internal and external stakeholders on Roche products’ safety profile and PV requirements
- Works as a business partner across all chapters and squads involved in activities that have PV implications
- Leads activities to ensure inspection readiness
- Oversees Individual Case Safety Report (ICSR) Processing and management of ICSRs from all relevant sources (solicited and unsolicited sources)
- Oversees reviews of PV Agreements, Safety Data Exchange Agreements (SDEAs) and other contracts with external third parties
- Ensures all safety information from internal/external stakeholders and vendors associated with Roche Products has been collected and reported as appropriate, which include but not limited to the following sources:
Roche-managed studies / IIS, MAPs, Medicines Assistance, MI Atlas, Technical complaints/counterfeit related issues, CRM, local media and local literature monitoring, Regulatory reports, Service provider oversight
- Provides safety advice to internal and external parties to ensure advanced product knowledge and safety of medicines May act as back up LSR / TGA Qualified Person for PV / TGA PV Contact Person, Vendor point of contact
Who you are:
You haveegree in pharmacy, other health disciplines, or life sciences
- Demonstrated experience in Pharmacovigilance (PV) or relevant experience in a GCP area preferred
- A thorough knowledge of GVP, ICH, GCP, TGA regulations, Medicines Australia Code of Conduct and other relevant regulations, standards and guidelines, - Medical terminology - verbal and written and an existing proficiency with PV systems and tools (e.g. ARISg) is preferred
- You are able to communicate in a concise and clear manner and good at building strong collaborative relationships with key stakeholders.
This role is only open to candidates who have full eligibility to live and work in Australia.