Director Principal Patient Safety Scientist

3+ years

Not Disclosed

Remote

10 Feb. 16, 2025

Job Description

Job Type: Full Time Education: PhD/MD/MBBS 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

Job ID: R-205150
Date Posted: 02/12/2025
Career Level: F
Location: Bengaluru

Job Description / Capsule:

Accountable for the performance and results across a team within the span of Patient Safety deliverables for Marketed Products. Responsible for setting team member objectives/plans to ensure the delivery of business objectives. Reviews and approves key drug safety documents and acts as the drug safety expert within their own team.

Typical Accountabilities:

Manage a team of Patient Safety staff locally.
Develop or use expertise to support the development of strategies and objectives for Patient Safety in the area of responsibility, ensuring alignment with broader AstraZeneca goals.
Maintain a high degree of understanding and awareness of internal and external trends influencing the Patient Safety domain and share insights with team members.
Build networks with other teams and external stakeholders to learn about new developments, leverage opportunities, and share best practices.
Manage or support projects aimed at improving processes within Patient Safety or introducing new technologies and approaches at national, regional, or global levels.
Ensure compliance with Good Clinical and Pharmacovigilance Practice, Safety Health and Environment (SHE) standards, and all other relevant internal and external regulations and standards.

Accountability For:

Oversight of Safety Surveillance and Medical Team (SSaMT) input to projects, including technical aspects, as well as line and resource management.
Deputizing for the PV Science Director as required.
Line management and team leadership responsibilities.
Recruitment, development, and retention of talent.
Full implementation of all Patient Safety and Global Medicines Development (GMD) strategic change programs within the team.
Sharing best practices across Patient Safety teams.
Partnering with the Qualified Person for Pharmacovigilance (QPPV), QPPV Office, and Patient Safety Risk Management Group.
Serving as a key member of the local leadership team and partnering with Senior PV Medical Directors.
Leading or contributing to local/global change and improvement projects.

Typical People Management Responsibility:

Direct/indirect reports: 10–12 (Manager of a team).

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 other life science degree or appropriate qualification as a Health Care Professional.
Experience as a Pharmacovigilance (PV) Professional (Scientist).
Experience in writing Risk Management Plans and assessing risk mitigation activities or translating preclinical safety experience to human applications.

Desirable:

Ph.D. in a scientific discipline.

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 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.

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Director Principal Patient Safety Scientist

Job Description

Job Description / Capsule:

Typical Accountabilities:

Accountability For:

Typical People Management Responsibility:

Education, Qualifications, Skills, and Experience:

Essential:

Desirable:

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