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ESSENTIAL KNOWLEDGE & SKILLS

• Scientific/ life-science background, medicinal knowledge preferred; proficiency in Medical terminology.
• Ability to handle multiple critical issues.
• Computer literate with basic knowledge of GMS database systems.
• Awareness of and familiarity with industry principles of drug development and pharmacology.
• Proficiency in global and local SOPs.
• Good verbal and written communication skill
• Ability to negotiate and communicate with internal and external customers.
• Ability to establish and maintain open relationships within the organisation and with authorities.
• Demonstrable knowledge of all local PV requirements and of global aspects of drug safety.

EXPERIENCE

• Scientific study and experience in pharmaceutical regulations and R&D processes.
• 4-6years Pharmaceutical industry experience including a PV responsibility role required.

PURPOSE

Local Medical Safety (LMS) ensures pro-active Benefit Risk Management throughout product life cycle by translating global safety data to insights and actions, and tailoring to local specificities and needs.
We support activities related to the pharmacovigilance regulatory requirements of Marketing Authorization Holders (MAH) and/or study sponsors, as applicable.
Please note that this role is available with the same job title, but different levels of experience. While you are welcome to apply to any or all of the postings, we recommend focusing on the experience that aligns with your profile.
2+ years of experience - R-020042
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

YOU WILL BE RESPONSIBLE FOR:

Ensuring the local Pharmacovigilance (PV) system is managed in compliance with local regulations and company policies/procedures at local, regional, and global levels and in accordance with any PV agreements with third party business partners.
Conducting local benefit-risk activities to ensure pro-active benefit-risk management throughout the product life cycle.