REQ-10053115
5月 27, 2025
Malaysia

摘要

#LI-Hybrid
Location: Selangor, Malaysia

Are you passionate about ensuring the safety of patients and upholding the highest standards in pharmacovigilance? At Novartis, we are looking for a dedicated and detail-oriented Patient Safety Specialist to join our team in Malaysia. This role is pivotal in supporting the management of patient safety operations, ensuring compliance with global and local regulations, and making a real impact on public health.

About the Role

Key Responsibilities:-

  • Manage the collection, processing, documentation, and follow-up of adverse event reports from all sources including clinical trials, literature, and spontaneous reports.
  • Ensure accurate and timely data entry into safety systems and liaise with external service providers when applicable.
  • Coordinate the reporting and submission of safety updates (e.g., SAE, SUSAR, PSUR) to local health authorities and internal stakeholders.
  • Develop and maintain local procedures aligned with global patient safety standards and national regulations.
  • Collaborate with cross-functional teams (e.g., Medical Affairs, Marketing) to ensure safety compliance in all initiatives involving data collection.
  • Oversee vigilance clauses in local contracts and ensure compliance with pharmacovigilance agreements.
  • Conduct reconciliation activities with departments like Medical Information and Quality Assurance for potential adverse events.
  • Prepare KPI reports, support audits and inspections, and implement corrective actions as needed.

Essential Requirements

  • Degree in Care Sciences (e.g., Medical Doctor, Nurse, Pharmacist) or equivalent life sciences background.
  • Strong knowledge of national and international pharmacovigilance regulations.
  • Familiarity with pharmacological and medical terminology.
  • Excellent communication and interpersonal skills.
  • High attention to detail with a quality- and results-oriented mindset.
  • Proficient in computer systems and safety databases.
  • Ability to work independently and manage multiple priorities in a compliance-driven environment.

Commitment to Diversity and Inclusion / EEO paragraph 

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? http://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: http://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards

Development
Innovative Medicines
Malaysia
Selangor
Research & Development
Full time
Regular
No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment.
REQ-10053115

Patient Safety Specialist

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