Job Description

Pharmacovigilance (PV) Associate supports the operations of PV processes for the APAC region ensuring compliance with internal procedures, contractual agreements and national/international regulations/standards/guidelines for PV of Clinigen licensed and unlicensed products (medicines, devices and biologicals). The role will work alongside the PV team and include coverage of Australia, New Zealand, Singapore, Hong Kong, Malaysia and neighbouring South East Asian countries.
Major Tasks & Activities:
Accuracy of information

• Manage and maintain efficient PV system and tasks as per safety agreements and local legislations
• Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all Link-related products ensuring accuracy according to timelines from clinical trials, non-interventional studies, literature, Spontaneous Reports, Managed Access Programs, etc
• Manage reporting/submission/distribution of safety reports/updates/information to Local Health Authorities in cooperation with internal stakeholders
• Establish and coordinate reconciliation activities with other departments and contractual partners in line with local PV SOPs and regulation
• Conduct periodic literature search to identify safety-related information for Link-related products
• Transcribe and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality
• Manage reporting/submission/distribution of safety reports/updates/information (e.g., SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR, Annual product reports) to Local Health Authorities and/or clinical operations in cooperation with other local departments
• Perform reconciliation with other departments and business partners for potential AEs resulting from medical inquiries, quality related complaints and other sources
• Conduct periodic literature search to identify safety-related information
• Input, review and approval of market research proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information as part of business development activities or for new product support
• Manage and maintain efficient pharmacovigilance filing and archive system

Accuracy of information

• Manage and maintain efficient PV system and tasks as per safety agreements and local legislations
• Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all Link-related products ensuring accuracy according to timelines from clinical trials, non-interventional studies, literature, Spontaneous Reports, Managed Access Programs, etc
• Manage reporting/submission/distribution of safety reports/updates/information to Local Health Authorities in cooperation with internal stakeholders
• Establish and coordinate reconciliation activities with other departments and contractual partners in line with local PV SOPs and regulation
• Conduct periodic literature search to identify safety-related information for Link-related products
• Transcribe and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality
• Manage reporting/submission/distribution of safety reports/updates/information (e.g., SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR, Annual product reports) to Local Health Authorities and/or clinical operations in cooperation with other local departments
• Perform reconciliation with other departments and business partners for potential AEs resulting from medical inquiries, quality related complaints and other sources
• Conduct periodic literature search to identify safety-related information
• Input, review and approval of market research proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information as part of business development activities or for new product support
• Manage and maintain efficient pharmacovigilance filing and archive system

Operational

• Serve as QPPV/ Deputy Qualified Person and local Safety Contact Person for applicable countries where required
• Serve as SME and supports local audits (internal & external)/inspections including readiness activities and development of CAPAs in response to findings
• Coordinate and support audits of contractual partners/vendors, as necessary
• Follow local procedure to ensure compliance with global and national requirements
• Coordinate and maintain PV agreements (e.g. SDEAs, safety agreements) relating to contractual partnerships (internal/external) in accordance with GVP
• Develop and maintain local PV-controlled documents (i.e. SOPs, training materials etc.)
• Support development of local procedure to ensure global quality PV data and evaluates processes for potential improvement in efficiency & effectiveness

Outcomes

• Support the preparation and conduct of PV and other GxP inspections and audits
• Review and maintain Risk Mitigating Plans (RMPs), conditions of registration and any other requirements with associated LINK-products
• Develop and maintain PV Key Performance Indicators (KPIs) in the region
• Provide support in making recommendation for local labelling changes

Personal Development

• Undertake training and development relevant to the job, including conferences and meetings
• Ensure up to date on related safety information and legislation in region

Additional duties:
This list of duties is not intended to be exhaustive but gives a general indication of the tasks involved. It is the nature of the company that tasks and responsibilities are, in many circumstances, unpredictable and varied. All employees are, therefore, expected to work in a flexible way when the occasion arises and acknowledge that tasks not specifically covered in their job description are not excluded.
Requirements

• Health Care Sciences Professional. (e.g., Medical Doctor, Nurse, Pharmacist, Medical Science or Science).

• Demonstrated solid pharmaceutical industry experience in PV/Drug Safety is preferred

• Sound experience with inspections/audits
• Knowledge of the pharmaceutical PV system in Australia (essential), other APAC countries (preferable)
• Experience in identification of critical situations/emerging safety issues from drug safety point of view
• Good understanding of signal detection and risk management
• Excellent interpersonal communication, organisational, and presentation skills
• Fluent in written and spoken English
• Excellent organizational and project management skills
• Extensive knowledge of MS Office Applications and systems
• Knowledge of national and international regulations for pharmacovigilance including causality, labelling, MedDRA, WHO-Drug coding and narratives
• Extensive knowledge of MS Office Applications and systems

Benefits

• 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.

Skills Required