Global Pharmacovigilance Agreements Manager
Qrios Minds AB / Biomedicinjobb / Göteborg
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hela Sverige This position will Working with the Pharmacovigilance Processes, Partnerships and Contracts (PV P,P&C) Lead, negotiating optimal safety agreements and contracts for AstraZeneca whilst establishing excellent collaborations and maintaining positive working relationships with third party partners (i.e. Licensing Partners).
Through the use of governance, relationship management, standardization and alignment ensure delivery in the most efficient lowest risk manner.
About the position
Job summary:
• Negotiate optimal, compliant, Pharmacovigilance (PV) Agreements for AstraZeneca whilst establishing excellent collaborations and maintaining positive working relationships with third party partners (i.e. Licensing Partners)
• Provide customers with expert advice, guidance and interpretation of matters pertaining to PV Agreements to demonstrate the value of Patient Safety as a key contributor to AstraZeneca internal and external business
• Collaborate with PS CoE, GPPS and Legal providing advice and support for commercial agreements ensuring that optimal and compliant PV obligations are included as required
• Collaborate with MC Safety Managers, providing advice and support for the creation and management of local PV Agreements
• Provide support to all LP audits as required and ensure remediation of findings.
• Coordination and ownership of the lifecycle management of the Licensing Agreements process enabling business continuity and compliance.
• Monitor standards and measures of compliance in relation to PV Agreements to support collaborations and continual improvement.
Responsibilities
Day to day duties:
Manage own workload ensuring all tasks assigned are completed on time. Tasks may include but are not limited to:
• Negotiation and establishment of new PVAs in timelines agreed.
• Review and updates of existing PVAs.
• Management of own PVAs - including compliance.
• Support any audits or inspections as needed.
• Support any other tasks as required.
Your profile
Required Skills/ Experience/ Education/ Qualifications:
• A science/pharmacy/nursing degree, or equivalent experience with at least 5 years relevant experience (pharmaceutical, regulatory, safety and partnership)
• Experience in working cross-functionally
• Thorough scientific knowledge sufficient to understand all aspects of regulatory/pharmacovigilance and partnership issues
• Thorough knowledge of the drug development process
• Good attention to detail
• Excellent written and verbal communication skills
• Proven ability to work across cultures
• Strong collaboration skills
• Strong negotiation, conflict management and interpersonal skills
• Relationship builder
• Able to work with high degree of autonomy and as a team
• Maintains high ethical standards, including a commitment to AstraZeneca values and behaviours
• Good time management
• Fluent in English
• Computer literate
Desirable Skills/ Experience/ Education/ Qualifications:
• MSC/PhD in scientific discipline
• Knowledge of new and developing regulatory and pharmacovigilance expectations
• Knowledge of existing AstraZeneca external alliances and collaborative projects
• Experience of working with third party suppliers.
• Experience of working in a global organisation, preferably within the pharmaceuticals industry, and of the drug development life cycle and commercial aspects of the industry
About the organisation
This position is a consultant assignment for one year at AstraZeneca via QRIOS Life Science & Engineering in Göteborg. During this time you will be employed by QRIOS Life Science & Engineering.
QRIOS employs curious experts in IT, Life Science and Engineering. We want to continue to attract the best employees, to continue to support our partners with the important competences you require. We are a recruitment and consulting company that is strongly inspired by those who never stop looking for new solutions. As we say, QRIOS MINDS GO FURTHER.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2022-01-11ErsättningFast lön
Så ansöker duSista dag att ansöka är 2022-01-19
Ansökan sker via företagets webbplats.
FöretagQrios Minds AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "126".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Qrios Minds AB (org.nr 556599-5999),
http://www.qrios.se/ Arbetsplats Qrios Life Science & Engineering AB
Kontakt Alma Foric
alma.foric@qrios.se 073-850 49 73 Jobbnummer 6236941
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