Associate Director Patient Safety Romania

Associate Director Patient Safety

Bucharest Romania

About AstraZeneca

AstraZeneca is a global science-led patient-focused biopharmaceutical company that focuses on the discovery development and commercialisation of prescription medicines for some of the worlds most serious diseases. But were more than one of the worlds leading pharmaceutical companies.

In Romania we are a team of over 350 dedicated professionals across various functions and therapeutic areas playing a vital role in advancing healthcare for Romanian patients. We are proud of a long heritage in partnering with local healthcare system to turn our ground-breaking innovative pipeline into life-changing therapeutic solutions. Find more about our team: and join our AZ team where you will play a pivotal role in this exciting period of development!!

Join us as an Associate Director Patient Safety driving country-level strategy and execution while contributing to global initiatives. This role may be managerial leading local teams and operations or technicalowning specialised projects within larger international programs. Youll use expert judgement to lead complex risk ensure compliance with local regulations and global PS requirements and coordinate end-to-end safety activities. Expect to advise on process and strategy analyse and trend data with stakeholders implement local improvements aligned to business objectives influence key decisions across local/multi-country projects and potentially lead junior colleagues.

• Act as national contact person (NCP) for pharmacovigilance Romania
• Maintaining an in-depth knowledge of the local health authority regulations and updating regional lead Cluster lead and local teams with any new changes in legislation/guidance for discussion and escalation to relevant stakeholders in global Patient Safety as required.
• Maintain local procedural documents associated with patient safety activities are up to date.
• Ensure local information relating to pharmacovigilance activities is reflected accurately in the Pharmacovigilance System Master File (PSMF)
• Maintain oversight of all safety-related processes issues and brand activities within their country including product risk management plans and associated activities.
• Maintain up-to-date knowledge of the marketed status of products in the local country and reference documents (such as Product Information/ core data sheet) in addition to maintaining up-to-date knowledge related to the global PS procedures/ Guidance.
• Lead Health Authority interactions and queries such as for ICSR-related products related safety concerns and educational materials associated with the Risk Management Plan (RMP)
• Fully trained on different global PS systems
• Support local safety management agreements and clinical study protocols to fulfil AstraZeneca and local regulatory safety reporting requirements.
• Support external patient safety service providers to meet AstraZeneca and local regulatory pharmacovigilance requirements.
• Acting as GVP Lead implementing all elements of Quality management systems related to patient safety (Change Management Continuous Improvement plan Issues Root Cause Analysis CAPAs Risks Self-assessment Management review meetings Vendor quality review PS Agreements Training & etc.)
• Support delivery of PS training to local staff and locally engaged vendors including annual refresher training.
• Ensures corrective and preventative actions are taken in the event of local non-compliance.
• Management of the PV aspects relating to Organised Data Collection Programmes Digital and Social Media activities and other arrangements with external parties (such as Externally Sponsored Research (ESR) health authorities partnerships or other collaborations).
• Support audit & inspection process & respond to all related queries and handle the identified gaps as per GVP.

• Degree in Pharmacy/ Medical/ Science
• Excellent Pharmacovigilance Knowledge
• Deep knowledge of Good Pharmacovigilance Practice
• Deep knowledge of health authoritys regulations
• Experience in cross function collaboration
• Leadership skills & act as a role model for the local PS team.
• Project management & experience on above-market PS projects.
• Effective thinking & problem solving
• Vendor management
• Patient Safety systems management.
• Audit & Inspection experience
• Excellent attention to detail
• Excellent written and verbal communication skills
• Excellent knowledge of English and local language both spoken and written

• Advanced scientific degree or equivalent experience
• Extensive Pharmacovigilance Knowledge
• Problem-solving Influencing and Conflict Resolution skills.
• Understanding of multiple aspects of Medical Affairs Regulatory Clinical Research and Commercial Operations
• Medical knowledge in AZ Therapeutic Areas
• Medical Marketing experience
• Change management skills

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Competitive salary and benefits package on offer!

The successful candidate will have access to a flexible employee benefits fund including holiday purchase and flexible time off pension contributions Share Save Plans A performance recognition scheme and a competitive generous remuneration package.

Why AstraZeneca

At AstraZeneca were dedicated to being a phenomenal Place to Work. You are empowered to push the boundaries of science and fuel your entrepreneurial spirit. Theres no better place to make a difference in medicine patients and society. An inclusive culture that champions diversity and collaboration and is always committed to lifelong learning growth and development. Were on an exciting journey to pioneer the future of healthcare.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.