Safety Data Executive – Lundbeck Export A/S

Lundbeck Export A/S

Lundbeck is a fast growing Danish pharmaceutical company, which specializes in psychiatry and neurology. We employ over 5000 people globally, and have a turnover of over USD1.5billion.

International Clinical Research, Asia Pacific, has been established to carry out local trials as well as participate in global clinical development programs. We are based in Singapore, and have Clinical Research Operations in most Asian countries. We are now expanding, and need the following specialist :

Safety Data Executive

You are to coordinate processes and handle safety data in close collaboration across therapeutic groups. To manage the process of single case handling in accordance with current SOPs & ISPV Safety Mailbox. Be an expert in safety data management processes and be knowledgeable of the general principles of pharmacovigilance.

Responsibilities:

• Perform data entry of adverse event reports
• Ensure daily handling of the ISPV Safety Mailbox across therapeutic teams
• Perform and manage enquiries for data clarification
• Perform and manage follow-up including initial identification of missing clinically relevant data
• Ensure replies to case-related enquiries
• Ensure case files are updated
• Participate in reconciliation and data cleaning
• Ad hoc contributions to the safety surveillance activities in ISPV, including SADR-listings
• Participate in and perform internal and external training relevant to the process of safety data management
• Participate in preparation, review, and maintenance of ISPV SOPs and templates
• Gain basic knowledge of pharmacovigilance and the therapeutic area
• Ensure up-to-date safety data management knowledge through participation in courses and meetings

Qualifications:

• Diploma or Degree in Nursing
• Good medical knowledge
• Must be able to converse & write in English fluently
• High level of computer literacy
• Independent, self-motivated, good team player, meticulous with good communication skills

Position is based in Singapore

Get started by forwarding your application together with your latest resume including expected salary.

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