Manager, Country Patient Safety Responsible

5 days ago

Selangor, Malaysia Sandoz Full time

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

- Building strong relationships with relevant functions in the affiliate organization (including but not limited to regulatory affairs, medical affairs, quality assurance, marketing and sales, clinical development and others), in collaboration with the Director/ Associate Director of the Patient Safety HUB and 3rd party vendors.
- As defined by local regulations act as the Local Qualified Person for Pharmacovigilance in the country(ies), you’ll act as the single point of contact with the Local Health Authority.
- Ensures the local management of adverse event information, with the following aspects (In collaboration with 3rd party vendor where routine operational activities may be partially or completely outsourced):

- Identification of sources of adverse event information, from any source in the country
- Maintaining oversight on case content and reporting
- Maintain awareness of product complaints received in the affiliate, ensure exchange and reconciliation of product complaints associated with adverse events and more.
- Collaborates with 3rd party vendor, Regulatory Affairs (RA) and other functions, ensure processes are in place to answer fully and promptly any safety related requests from Local Health Authorities and maintains oversight on results of the signal management process, including any relevant subsequent actions, such as safety variations, ARMM, or ad hoc safety measures.
- Ensures the local Pharmacovigilance requirements are met. This is not limited to identifying specific requirements that may not be covered by global procedures and communicate to the Sandoz regional hub. Where required, implement local procedures to supplement PS global procedures and to ensure compliance national requirements.
- Ensure that all local internal and external stakeholders are adequately trained from pharmacovigilance obligations.
- Collect and share relevant metrics for local business volumes and performance. Participate in governance meetings at regional and global level to have oversight on the performance of the PV system.
- Promote innovation to improve processes and deliverable quality and take every opportunity to use the projects for teaching and developing team members.

**What you’ll bring to the role**:
Essential Requirements
- Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist) or equivalent education, training, and experience.
- Minimum 5 years’ experience in drug-safety or pharmacovigilance (preferred) and/ or experience in pharmaceutical industry
- Minimum 2-3 years of demonstrated leadership and accomplishment in all aspects of patient safety in a local/matrix environment in the pharmaceutical industry. This includes extensive knowledge of regional and local requirements relating to PV (PV processes, compliance, databases, QA, training, audits and inspections). Ability to solve complex regulatory issues and requirements.
- Ability to effectively communicate with different stakeholders.
- Demonstrated track record to successfully lead/work in interdisciplinary global teams; leading, planning, and prioritizing activities simultaneously on multiple projects.
- Experienced leader in a matrix organization, including ability to influence and provide guidance and direction to team members.
- Demonstrated ability for innovative and big picture thinking.
- Strong planning, negotiation, organizational and interpersonal 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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