Medical Safety Advisor – 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 :

Medical Safety Advisor

You are to perform medical safety management of Lundbeck products, from Phase I and on through the entire life cycle. To act as a Medical Advisor on product safety.

Responsibilities:

• Contribute to overall GPvP of medical safety tasks in handling of single case reports, periodic safety reports, clinical trial safety evaluations, literature surveillance, signal detection, risk management activities, and responses to authority requests
• To be a specialist within pharmacovigilance and the therapeutic area
• Medical Advisor for Safety Sections of core SPCs and related global product labelling
• Contribute to professional representation of ISPV within and outside Lundbeck
• Timely communication of potential safety signals to line management
• Participate in internal training according to individual needs and ISPV standards
• Adhere to relevant Lundbeck corporate, ICR, and ISPV SOPs, Working Instructions, and templates

Qualifications:

• Medical doctor by training
• Good medical knowledge
• Must be able to converse & write in English fluently
• Good 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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