Local Medical Safety Specialist, Malaysia, Brunei & Indonesia

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Job Function:
Product Safety

Job Sub Function:
Pharmacovigilance

Job Category:
Scientific/Technology

All Job Posting Locations:
Petaling Jaya, Selangor, Malaysia

Job Description:

The Local Medical Safety Specialist, supports pharmacovigilance activities for Johnson & Johnson products across Malaysia, Brunei and Indonesia, ensuring local safety systems, processes and activities remain compliant with applicable regulations, company procedures and PV agreements.

The Local Medical Safety Specialist, Malaysia will report to and work closely with the Cluster Safety Lead, Malaysia, Brunei and Indonesia within the Local Medical Safety (LMS) organization to support oversight of local PV operations, compliance, risk management and stakeholder engagement:


* Support oversight of Local Operating Company (LOC) pharmacovigilance activities across Malaysia, Brunei and Indonesia, ensuring compliance with local regulations, company policies/procedures and applicable third-party PV agreements.


* Support maintenance of appropriate PV, risk management and record management processes to enable effective oversight of products within scope.


* Manage Local Medical Safety activities to:
+ Enable proactive benefit-risk management throughout the product lifecycle by translating global safety information into locally relevant insights and actions.
+ Support safety reporting and related PV activities required by Marketing Authorization Holders (MAHs), study sponsors and applicable local requirements.

PRINCIPLE RESPONSIBILITIES


* Act as Locally Nominated Back-up Person for Pharmacovigilance
+ Serve as the locally nominated back-up PV contact, as required by national law/regulation, and collaborate with QPPV offices or relevant PV leadership as applicable.



* Safety Management & Reporting:
+ Support local processes and systems for end-to-end management of adverse events, product quality complaints with adverse events, special situation reports and related safety information.
+ Support timely management and submission of safety information in line with company procedures and local regulatory...