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Job position: Associate Director Patient Safety Process & Partnership
Job Locations:
India – Bangalore
Job ID : R-179145
Job Description:
Do you have knowledge in regulatory/pharmacovigilance and partnership issues ? Do you have a “can do” attitude and an innovative approach and want to contribute to ensure good relationships across Patient Safety and related functions within Astra Zeneca and Alexion? Then this unique role with a broad spectrum of responsibilities might be the one for you!
At AstraZeneca, we turn ideas into life changing medicines and strive to continuously meet the unmet needs of patients worldwide. Ensuring AstraZeneca comply with Pharmacovigilance regulations is key and in our team we make sure to make this a reality.
To meet our business priorities and address resource demands, we are now looking for you who wants to join our Global PS Operations, Technology & Analytics group in Patient Safety, CMO as an Associate Director in the ICSR Process & Partnership team.
We are responsible for the management of assigned AstraZeneca projects, processes and partnerships including implementation, communication, compliance, performance, vendor oversight and inspection readiness within the ICSR area
. We ensure good relationships across Patient Safety in CMO and other relevant areas of AZ to execute the delivery of the processes and partnership strategy, priorities, alongside governance and management of the current procedural documents and partnershipsWhat you’ll do
As an Associate Director you will be working with Directors and Associate Directors in PV Processes, Partnerships and Contracts area, taking responsibility for the management of ICSR process and vendor oversight in AstraZeneca, covering processes and partnerships including implementation, communication, compliance, performance and inspection readiness. You will be accountable to develop relationships across Patient Safety in CMO and other relevant areas of AZ to execute the delivery of the processes and partnership strategy, priorities, alongside governance and management of the current procedural documents and partnerships.
Here you will have a great opportunity to use your deep understanding of regulatory and pharmacovigilance processes and regulations providing process or compliance support to safety and regulatory teams and submissions as well as to develop and maintain a vision and strategy for nominated pharmacovigilance or regulatory processes. In addition you will:
- Identify opportunities for and drives the enhancement of existing processes and partnerships through knowledge of internal and external environment
- Working with the PV Process, Partnership and Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to safety and regulatory data reporting
- Utilise safety and regulatory knowledge to maintain and support the global inspection readiness strategy
- Manages relationships/partnerships/alliances external to the AZ CMO function that are essential to delivering AstraZeneca’s pharmacovigilance and regulatory LTO responsibilities
- Identify opportunities for and drives the enhancement of existing processes and partnerships through knowledge of internal and external environment
- Working with the PV Process, Partnership and Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to safety and regulatory data reporting.
- Utilise safety and regulatory knowledge to maintain and support the global inspection readiness strategy.
- Manages relationships/partnerships/alliances external to the AZ CMO function that are essential to delivering AstraZeneca’s pharmacovigilance and regulatory LTO responsibilities
- Provide support and oversight to the outsourcing partner(s) to facilitate compliance with regulatory and legal requirements and maintaining inspection
- With this in mind, we are looking for you that have a proven ability to work across cultures using your strong negotiation, conflict management and interpersonal skills to influence whilst maintaining independent and objective view.
Essential for the role for Associate Director at AstraZeneca
- A science/pharmacy/nursing degree, with at least 5 years relevant experience (pharmaceutical, regulatory, safety and partnership)
- Experience in working cross-functionally
- Leadership skills, including proven leadership of project teams experience
- Thorough scientific knowledge sufficient to understand all aspects of regulatory/pharmacovigilance and partnership issues
- Thorough knowledge of the drug development process
Desirable for the role
- 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 in safety database functionalities
Why AstraZeneca?
Our purpose is ambitious and so is our approach. Becoming a more agile and innovative company means building a dynamic, inspiring culture where we celebrate forward thinking and act with a sense of urgency. We are ambitious, take informed risks and learn from both success and failure. We are curious, creative and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Are you ready to move forward in your career?
Join us and be part of an outstanding place to work; an environment that energizes and empowers each of us to achieve our personal and organizational goals!
So, what’s next!
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you. We welcome you with your application, no later than, 27 September, 2023.
Possible interview questions may be asked for Associate Director at AstraZeneca
1. Can you describe your experience in regulatory and pharmacovigilance processes within the pharmaceutical industry?
Answer: Certainly. I hold a science/pharmacy/nursing degree and have accumulated over 5 years of relevant experience in pharmaceuticals, specifically in regulatory and pharmacovigilance areas. This experience includes a deep understanding of regulatory and safety processes, ensuring compliance with industry standards and regulations.
2. How do you ensure effective communication and collaboration between cross-functional teams in a global organization?
Answer: Effective communication and collaboration are vital in a global organization. I have a proven track record of working cross-functionally, leveraging strong leadership and interpersonal skills. I encourage open communication, create a collaborative environment, and use my negotiation and conflict management skills to drive alignment across teams.
3. Can you provide an example of a situation where you had to enhance an existing process or partnership? What was the outcome for an Associate ?
Answer: Certainly. In a previous role, I identified opportunities to improve an existing partnership, which resulted in streamlined processes and improved compliance. By working closely with the team and external partners, we implemented changes that led to more efficient operations and better regulatory data reporting.
4. How do you stay updated with evolving regulatory and pharmacovigilance expectations in the pharmaceutical industry?
Answer: Staying updated is crucial in our field. I actively monitor industry trends, regulatory updates, and emerging expectations. I also engage with professional networks and organizations, attend relevant conferences, and leverage resources to ensure our practices align with the latest standards.
5. Can you share your experience with managing relationships with external partners and alliances?
Answer: I have experience managing relationships and alliances external to the organization. This includes collaborating with third-party suppliers and ensuring they comply with regulatory and legal requirements. Effective management of these relationships is essential to fulfilling our pharmacovigilance and regulatory responsibilities.
