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Specialist, Country Patient Safety

3 weeks ago

Selangor, Malaysia Sandoz Full time

**Your Key Responsibilities**:
Your responsibilities include, but not limited to:

- Ensure the local management of adverse event information, in collaboration with 3rd party vendors.
- Ensure exchange and reconciliation of product complaints associated with adverse events.
- Contribute to the planning of periodic reports to meet local compliance obligations, submit reports authored by global functions.
- Participate in the implementation of local RMP commitments and effectiveness checks in addition to the participation in the development and implementation of local procedures to supplement PS global procedures and to ensure compliance national requirements, where required.
- Participate in the preparation of Patient Safety training materials and the organization of these trainings in the affiliate, including preparation of confirmations and certificates.
- Create KPI reports and participate in compliance governance to monitor compliance, participate in investigation of root causes and creation of corrective/preventative actions for any non-compliance.
- Deviation and CAPA- Document local deviations and participate in the implementation of any corrective/ preventative action.

Management and distribution of vigilance clauses to other departments (such as Legal, Procurement, etc.) to be included in local agreements and provide

**What you’ll bring to the role**:
Essential Requirements
- Possesses a Health Care Sciences background/ prior profession (e.g., Medical Doctor, Nurse, Pharmacist) or equivalent education, training, and experience
- Ideally 2 years’ experience in drug-safety or pharmacovigilance and/ or experience in pharmaceutical industry
- Knowledge of national and international regulations for pharmacovigilance
- Knowledge of pharmacological and medical terminology
- Good communication and interpersonal skills
- Quality and results oriented
- Project management skills

**Why Sandoz?**

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

The future is ours to shape

Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

**#Sandoz**

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