Director Principal Patient Safety Scientist

10+ years

Not Disclosed

Bangalore

10 July 25, 2024

Job Description

Job Type: Full Time Education: PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

As the Director Principal Patient Safety Scientist, you will be responsible for overseeing a team focused on patient safety deliverables for marketed products. You will set team objectives and plans to ensure the achievement of business goals. Your role will include the review and approval of key drug safety documents and acting as the primary drug safety expert within your team.

Typical Accountabilities

Team Management: Lead a local team of Patient Safety staff, ensuring their work aligns with AstraZeneca's broader goals and objectives.
Strategy Development: Develop or utilize expertise to support patient safety strategies in your area of responsibility, ensuring alignment with broader AstraZeneca goals.
Industry Awareness: Maintain a strong understanding of internal and external trends affecting the patient safety domain, sharing relevant insights with your team.
Networking and Collaboration: Build networks with other teams and external stakeholders to stay updated on new developments, leverage opportunities, and share best practices.
Process Improvement: Manage or support projects aimed at improving patient safety processes or implementing new technologies at national, regional, or global levels.
Regulatory Compliance: Ensure that all work complies with Good Clinical and Pharmacovigilance Practices, Safety Health and Environment standards, and other relevant regulations.

Accountability for

Oversight of Safety Signal Management Team (SSaMT) inputs to projects, including technical and resource management.
Acting as Deputy for the PV Science Director when needed.
Leading line management and team leadership responsibilities, including recruitment, development, and retention of talent.
Implementing all Patient Safety and Global Medicines Development strategic change programs within the team.
Sharing best practices across patient safety teams.
Partnering with the Qualified Person for Pharmacovigilance (QPPV) office and the PS Risk Management Group.
Being a key member of the local leadership team and collaborating with Senior PV Medical Directors.
Leading or participating in local/global change and improvement projects.

People Management Responsibility

Managing a team of approximately 10–12 individuals.

Education, Qualifications, Skills, and Experience

Essential:

Medical degree.
Experience in patient safety within the pharmaceutical industry.
Excellent communication skills.
Project management experience.
Knowledge of relevant legislation and developments in the pharmaceutical industry.
Medical or life science degree, or relevant qualification as a healthcare professional.
Experience in writing Risk Management Plans, assessing risk mitigation activities, or translating preclinical safety experience to human applications.

Desirable:

Ph.D. in a scientific discipline.

Date Posted: 22-Jul-2024
Closing Date: 01-Aug-2024

Commitment to Diversity and Inclusion

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, perspectives, and skills. We believe that a more inclusive environment leads to better work outcomes. We welcome applications from all qualified candidates, regardless of characteristics, and comply with all applicable laws and regulations on non-discrimination in employment, as well as work authorization and employment eligibility verification requirements.

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