Medical Information Associate at Clinigen

Shah Alam, Selangor, Malaysia -

Full Time

Start Date

Immediate

Expiry Date

22 Jan, 26

Salary

0.0

Posted On

24 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medical Information, Pharmacovigilance, Communication Skills, Attention to Detail, Time Management, Customer Focus, Medical Literature Understanding, Computer Applications

Industry

Pharmaceutical Manufacturing

Description

The role is responsible for the delivery of a high-quality medical information service to internal and external users of the service across all business functions, which is compliant with external regulations and internal company policies. The Medical Information Associate role is ideal for an individual with an awareness or understanding of medical information who is looking to develop or gain exposure in assisting in the growth of a medical information department. Knowledge of pharmacovigilance is also an advantage. Job Description Ensure the provision of an efficient, comprehensive and professional MI service to internal and external customers in line with industry standards Manage MI enquiries in a timely manner for Clinigen products and MI enquiries for other Pharmaceutical Client products, where Clinigen is contracted to provide MI support, ensuring all pertinent regulations and processes are adhered to Liaise with multiple internal and external stakeholders as required for handling of medical information enquiries Accurate documentation of MI enquiries in the MI enquiry tracker Ensure all patient safety issues and product quality complaints are escalated appropriately and in line with standard operating procedures Respond to all medical information support requests from internal departments without delay and in a timely fashion and within the timelines as documented in internal procedures Generate, distribute and track Monthly Line Listing reports to clients Support the collation of MI Compliance metrics, Key Performance Indicators (KPI) and Quality Review reports Perform reconciliation activities of received medical Information enquiries, product complaints and adverse events with other internal and/or external stakeholders as required Update and communicate changes to product SPCs and Patient Information Leaflets to external and internal stakeholders (e.g. eMC, MIMS, BNF, distributors, partners, etc) Develop and maintain a thorough knowledge of the company’s products Ensure all pertinent regulations and processes are adhered to Contribute to and ensure process and system improvement, including support of new services Contribute to quality related activities including change control management, CAPA (Corrective and Preventative Action) and deviation management Represent medical information in cross-functional team meetings, as required Develop an understanding and stay up to date with the relevant industry codes of practice, eg. EFPIA, UK ABPI, Medicines Australia, Medicines New Zealand, HKAPI, PhAMA, and SAPI codes of Practice Support the preparation and development of MI Standard Response Documents i.e. Frequently Asked Question (FAQ), Standard Letters and Data on File documents Support preparation for medical information in internal and external audits and inspections, as required. Qualified up to BSc or equivalent life science degree 3 to 4 years of relevant working experience Demonstrable knowledge of Medical Information Excellent communication skills – both written and verbal Ability to use computer applications such as Word, Excel, PowerPoint, Adobe Pro Ability to understand medical literature and medical terminology Understanding of the basic principles of GDP Evidence of being able to build relationships with key internal and external customers and demonstrate customer and patient focus Proven experience of working to meet high standards and provide excellent customer service Good attention to detail and evidence of ability to work under pressure Prioritization and time management skills In return for your valuable contributions and commitment to our organization, we are pleased to offer you an attractive and comprehensive benefits package that includes: A competitive monthly salary that reflects your experience, skills, and the industry standards, ensuring that you are fairly compensated for your hard work and dedication. A performance bonus designed to reward exceptional performance and achievements, providing you with additional financial incentives as you excel in your role. Generous annual leave of 20 days, allowing you the opportunity to take time off for rest, relaxation, and personal pursuits, promoting a healthy work-life balance. Ongoing professional development opportunities, including training programs, workshops, and access to resources that will help you enhance your skills and advance your career within our organization.

Responsibilities

The Medical Information Associate is responsible for delivering a high-quality medical information service to internal and external users while ensuring compliance with regulations and company policies. This includes managing inquiries, documenting them accurately, and liaising with stakeholders.