Pharmacovigilance Manager

Zuellig Pharma is a leading healthcare solutions company in Asia, and our purpose is to make healthcare more accessible to the communities we serve. We provide world-class distribution, digital, and commercial services to support the growing healthcare needs in this region. 

The company was started a hundred years ago and has grown to become a multibillion-dollar business covering 17 markets with over 12,000 employees. Our people serve more than 200,000 medical facilities and work with over 450 clients, including the top 20 pharmaceutical companies in the world. 

DUTIES AND RESPONSIBILITIES 

• Accountable for accurate data collection, reporting and handling of adverse event reports from all relevant sources including literature articles, associated with Zuellig Pharma in-licensing products, in accordance with Zuellig Pharma, principals and local regulatory authority requirements. 

• Accountable for submission of Individual Case Safety Reports (ICSRs) to regulatory authority, ensuring compliance with Zuellig Pharma, principals and local regulatory requirements authority and timeline. 

• Provide safety-related information to local stakeholders, principals, for the preparation of Aggregate Reports, when necessary. 

• Ensure submission of Aggregate Reports (PSURs/ PBRERs/ DSURs) as applicable to local regulatory authorities in accordance with Zuellig Pharma, principals and local regulatory authority requirements. 

• Ensure appropriate safety reporting processes are in place, if applicable, described in relevant local documents, for interventional clinical trials, Non-Interventional Studies (NISs), Market Research and Patient Support Programs (PSPs) and Compassionate Use in accordance with Zuellig Pharma, principals and local regulatory authority requirements. 

• Act as Zuellig Pharma’s point of contract for safety and support internal and external safety activities in collaboration with internal and external stakeholders. 

• Assuming responsibility for PV related education and training for relevant personnel. 

• Oversight Medical Information (MI) activities and back-up person for MI activities. 

• Management of PV and MI team 

Qualification:  

• Degree/ advanced degree in medicine, pharmacy or in life sciences or equivalent experience. 

• Several years of experience in the pharmaceutical industry in pharmacovigilance or clinical research or product development. 

• Good problem solving and decision-making skills. 

• Team building and team management experience. 

• Strong interpersonal skills, with a demonstrated ability to manage people and teamwork. 

• Excellent communication and negotiation skills – ability to manage discussions and decision making across cultures. 

• Excellent skills in time management and change management, organizational and facilitation skills.