Experience

PT. OTSUKA INDONESIA

• Indonesia
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Medical Affairs Advisory

  • Jul 2022 - Present



PT Otsuka Indonesia

• • Apr 2014 - Mar 2022

  1. Participate in customer and potential customer meetings when medical strategies are of importance.2. Provides medical support for the evaluation process for new customers.3. Ensures all medical objectives are met in full compliance with law, regulations, standards of business conduct and corporate integrity agreement.4. Provides medical input to all aspects of product development.5. Review clinical results and develops and assists in the development of appropriate communication vehicles i.e. scientific publications, posters, presentations, etc.6. Provides direction for the medical information team.7. Provides medical support and guidance to the change management team.8. Participates in conferences and scientific meetings to maintain awareness of research in the field.9. Keep abreast of current state-of-the-art developments relating to in-house medical program focus, and provides education to clinical staffs and other project team members as needed.10. As needed, assists Senior Director in evaluating potential business opportunities.Head of Pharmacovigilance - Local Safety Manager (LSM)PV Major Responsibilities:1.Develops and maintains local PV SOPs to adapt the procedures in the Otsuka Global and Regional PV SOPs with the regulations, guidelines and practical procedures in Indonesia.2.Keep abreast current applicable PV regulatory requirements, guidelines and their interpretations in Indonesia, and informs regional PV Center of any change of the regulatory requirements.3.Prepares and submits all safety reports to Regional PV Center.4.Ensures the quality and continuity of data and accurate reporting of safety information to Regional PV Center.5.Ensure compliance with relevant PV regulations and Guidelines in the country.6.Ensure compliance with local and Otsuka global SOP(s).7.Assess the safety profile of Otsuka medicinal products.8.Represent the Affiliate on PV issues at Otsuka global level. Show less

• • Sep 2012 - Mar 2014

  Supporting Marketing & Sales Department for any scientific activities and Clinical Trials.Head of Pharmacovigilance.

• • Apr 2009 - Aug 2012

  In charge in Therapeutic Drug Division and supporting Marketing & Sales Department.Back up Local Safety Manager for Pharmacovigilance Department

• • Mar 2008 - Apr 2009

  In charge in Clinical Nutrition Products for any scientific marketing activities



Materna Hospital

• Clinical Medical Officer

  • 1998 - 2008

  Head of outpatient department Head of outpatient department