Job Description

The Pharmacovigilance Specialist will be the deputy Local Responsible Person for Pharmacovigilance (LPPV) on behalf of the company for regional country, mainly China. This includes ensuring compliance with the regulations set forth by the National Medical Products Administrations (NMPA) and the National Pharmaceutical Regulatory Agency (NPRA) and overseeing all pharmacovigilance (PV) activities.

• If necessary, receive, translate, and forward Adverse Events (related to medicinal products, cosmetics, biocides, nutritional) with or without Product Technical Complaints to Global Pharmacovigilance & Risk Management (GPRM) or relevant partners. Ensure proper documentation of Adverse Events, perform reconciliation activities, and maintain accurate records.
• Submit Individual Case Safety Reports (ICSRs) and Aggregate reports to local health authorities as required, and maintain appropriate documentation of these submissions.
• Stay updated on changes in the local regulatory environment, including monitoring local health authority websites for ICSRs and relevant safety requirements. Inform GPRM of any significant safety updates.
• Provide support during local audits, inspections, and related processes, and assist in the preparation and management of Corrective and Preventive Actions (CAPAs).
• Adhere to the responsibilities outlined for Local Responsible Person for Pharmacovigilance (LPPV) as per regulations issued by the National Pharmaceutical Regulatory Agency (NPRA). Oversee and manage all pharmacovigilance activities in Malaysia.

A company with a rich heritage and a strong presence in the medical industry. |Commitment to the professional growth and development of its employees.

• Study background: Bachelor\'s degree or professional qualification, preferably with major in Life Science or equivalent.
• A minimum of 2 year\'s experience in Pharmacovigilance and/or Post Marketing Surveillance (PMS) or related area in the pharmaceutical industry or medical environment.
• Have fluent oral and written communication skills in English and Mandarin.
• In-depth knowledge of both local and international regulations pertaining to pharmacovigilance.
• Outstanding strategic planning with the ability to develop actionable solutions and recommend strategies.
• Proficient in Microsoft Office applications such as Word, Excel and Powerpoint.

Our client is a reputable international company within the medical industry. They are known for their commitment to contributing to the advancement healthcare products and play a part in enhancing the quality of life for countless individuals. The company offers various training programs and a supportive work environment that fosters continuous learning and advancement. Joining them provides a platform for you to expand your skills, take on new challenges, and grow your career in the dynamic field.

• Regional exposure to countries mainly China
• Vast opportunities for career growth and progression
• Strong internal and external stakeholder engagement (both Local and Regional)
• Professional development is available as the company cultivates a supportive environment

Michael Page