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Director Principal Patient Safety Scientist

2+ years
Not Disclosed
10 Dec. 12, 2024
Job Description
Job Type: Full Time Education: PhD/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Director Principal Patient Safety Scientist

Career Level: F
Location: Bengaluru


Job Description / Capsule

The Director Principal Patient Safety Scientist is accountable for the performance and outcomes of a team within the Patient Safety function for marketed products. This role encompasses oversight of drug safety deliverables, team management, and strategic input. It also involves review and approval of critical safety documents while serving as the drug safety expert within the team.


Key Responsibilities:

Team Leadership:

  • Manage a team of Patient Safety professionals locally.

  • Set team objectives and plans to ensure alignment with broader AstraZeneca goals.

  • Foster talent recruitment, development, and retention within the team.

  • Lead the implementation of Patient Safety and Global Medicines Development (GMD) strategic changes.

Operational Oversight:

  • Ensure compliance with Good Clinical and Pharmacovigilance Practices (GCP/GVP), Safety Health and Environment (SHE) standards, and other relevant regulations.

  • Provide oversight of Safety Strategy and Management Team (SSaMT) input into technical projects.

  • Deputize for the Pharmacovigilance (PV) Science Director as needed.

Strategic and Process Improvement:

  • Develop and support strategies and objectives for Patient Safety that align with AstraZeneca’s broader goals.

  • Engage in or lead local/global change and improvement initiatives.

  • Build external and internal networks to share and adopt best practices and leverage opportunities.

Stakeholder Management:

  • Partner with the Qualified Person for Pharmacovigilance (QPPV) office, PS Risk Management Group, and Senior PV Medical Directors.

  • Participate as a key member of the local leadership team to ensure cohesive strategy execution.


Qualifications, Skills, and Experience

Essential:

  • Medical degree or equivalent qualification as a healthcare professional.

  • Experience in Patient Safety within the pharmaceutical industry.

  • Strong knowledge of relevant legislation and industry developments.

  • Proven project management experience.

  • Experience in writing Risk Management Plans (RMPs) and assessing risk mitigation activities, or translating preclinical safety into human context.

  • Excellent communication skills to manage internal and external stakeholders effectively.

Desirable:

  • Ph.D. in a scientific discipline.

  • Experience in leadership roles involving cross-functional collaboration and strategic planning.


Accountabilities:

  • Oversight of SSaMT activities and technical projects.

  • Delivery of team objectives and leadership in implementing change initiatives.

  • Collaboration across teams to share best practices.


About AstraZeneca:

AstraZeneca values diversity and is committed to building an inclusive team that brings diverse perspectives and industry-leading skills. We welcome applications from all qualified candidates, fostering a workplace where everyone can thrive.

For further details, please visit AstraZeneca Careers.