Manager, Senior Patient Safety Scientist

AstraZeneca India; Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

An innovative pharmaceutical company is seeking a Manager, Senior Patient Safety Scientist in Singapore. The role involves leading pharmacovigilance activities, ensuring compliance with regulations, and providing strategic input for safety assessments. Candidates should have extensive experience in patient safety and a strong background in biosciences, coupled with excellent communication and teamwork skills.

Qualifications

• Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background.
• 6 to 9 years of Patient Safety experience with clear evidence of delivery.
• Comprehensive understanding of applicable Patient Safety regulatory obligations.

Responsibilities

• Perform all Surveillance activities including periodic report production.
• Lead monthly signal-detection activities and SIRC activities for established products.
• Produce high-quality responses to safety queries.

Skills

Interpersonal Skills

Cross-functional Teamwork

Communication Skills

Autonomy

Education

Degree in biosciences or equivalent

Job description

Manager, Senior Patient Safety Scientist

Job Title: Manager, Senior Patient Safety Scientist

Career Level: D

Introduction:

The Manager, Senior Safety Scientist works collaboratively with the Global Safety Physician (GSP) and SSaMTL or as a SSaMTL should lead scientific, technical, or Patient Safety input for a product, group of products, systems, or processes. He/she has the ability to provide authoring and PV input to safety documents and regulatory reports. The Manager, Senior Safety Scientist also has the ability to lead meetings and present safety data and analyses.

Main Responsibilities:

• Perform all Surveillance activities including periodic report production, leading monthly signal-detection activities and SIRC activities for established products.
• Authors/provides strategic input or oversight for periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
• Able to produce high-quality and timely responses to safety queries.
• Identify and use appropriate sources of information and database searches to retrieve relevant data for evaluation of signals for all products in area of responsibility.
• Support a performance-driven culture.
• Raise appropriate concerns/issues to senior staff in a timely manner.
• Serve as Safety Strategy and Management Team (SSaMT) leader for slightly more complex products.
• Perform end-to-end Pharmacovigilance activities independently on assigned products and mentor others within their role.
• Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes, and procedures.
• Provide strategic & scientific input into regulatory submissions, queries, and discussions.
• Support responses to queries/impositions by regulators, with high attention to implications in other countries.
• Ensure good communication and guidance to AZ products.
• Liaise effectively and maintain excellent relationships with external contacts.

Minimum Requirements:

• Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background.
• Proven competency in patient safety/clinical development.
• Comprehensive understanding of applicable Patient Safety regulatory obligations in EU.
• Awareness of Patient Safety policies, processes, and procedures.
• Awareness of medico-legal aspects of patient safety.
• 6 to 9 years of Patient Safety experience with clear evidence of delivery.
• Total of 10 to 12 years of experience.

Skills and Capabilities:

• Ability to work effectively as a member of a cross-functional or global team.
• Ability to work with autonomy.
• Ability to acquire and assimilate knowledge in different disciplines, disease, and therapeutic areas.
• Good communication skills with ability to work across cultures.
• High ethical standards, including a commitment to AstraZeneca values and behaviors.
• Ability to appreciate diversity and work as equals with global and cross-functional teams.

Communication:

• Well-developed interpersonal skills.
• Cultural sensitivity.
• Ability to network with other functions globally.

Internal and External Contacts/Customers:

• Patient Safety personnel at all levels.
• Regulatory Affairs and other AstraZeneca personnel.

This job posting appears to be active and not expired.