Pharmacovigilance Associate

uellig 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 

• Manage and maintain active involvement in day-to-day AE reporting. 

• Collection, reporting and handling of safety information associated with company in-licensing products to relevant principals according to Zuellig Pharma and principal’s time frames. 

• Local literature review and report AEs form local literature search. 

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

• Track AE cases and perform case follow-ups as needed. 

• Perform regular reconciliation activities as required by Zuellig Pharma procedures and local regulatory authority requirements. 

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

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

• Submission of safety queries, other significant safety issues performed according Zuellig Pharma, principals and local regulatory authority requirements. 

• Support internal and external PV audits or inspections. 

• Support internal and external safety activities in collaboration with internal and external stakeholders. 

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

Medical Information Responsibility (30% - 50%) 

• Handle calls requesting product information from HCPs and other customers. 

• Handle customers’ queries by providing balanced, accurate and non-promotional information in a courteous, professional manner with predefined answers/ resources. 

• Identify queries containing either adverse events or product quality complaints, handle and document these in accordance with the appropriate SOPS. 

• Accurately record and medical and pharmaceutical communication transaction into the appropriate database. Documentation is to be concise, thorough, and accurate in accordance with Good Documentation Practices. 

• Support the company with maintenance of the knowledge database. 

• Facilitate fulfilment of customers’ requests. 

• Escalate all enquiries without predefined answers according to principals’ requirements. 

• Ensure optimal customer satisfaction. 

• Participate in internal and external educational opportunities relevant to the function or customer service environment. 

• Perform local literature review according to local SOPs and principals’ requests. 

• Oversight the scope and number of local journals to be reviewed every year. 

• Monthly reconciliation with relevant functions adverse events or product quality complaints. 

Qualification:  

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

• Ability, with supervision, to solve routine problems and to surface issues constructively. 

• Ability to make basic decisions with an understanding of the consequences. 

• Ability to achieve personal objectives while meeting departmental standards of performance. 

• Some experience of Pharmacovigilance process and activity. 

What We Offer: 

• We are committed to fostering an inclusive environment where our employees can learn, grow, and achieve shared success. 

• We champion diversity, equity, and inclusion, ensuring every individual feels valued, respected, and treated fairly. 

• As a leading multi-market healthcare solutions provider, we empower our employees to gain comprehensive knowledge and expertise in the dynamic healthcare industry across the region. 

• Enjoy the flexibility to effectively balance your work and personal life while taking charge of your career journey through our empowering growth opportunities.

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