Pharmacovigilance Associate (0.5 FTE) - Part-Time

About Us

Specialised Therapeutics (ST) is the region’s largest independent specialty pharmaceutical company, providing new therapies and technologies to patients in Australia, New Zealand and across Southeast Asia. We partner with global pharmaceutical, biotech and diagnostic companies to bring novel healthcare opportunities to patients who are impacted by a range of diseases. Our mission is to provide specialty therapies where there is an unmet need. Our broad therapeutic portfolio currently includes novel agents in oncology, haematology, CNS, neurology, endocrinology, ophthalmology and supportive care, although it is not confined to these areas. 

Culture

ST has carefully cultivated a work environment in which our employees are constantly challenged to do their best and think differently. Our company is determinedly inquisitive, perceptive and courageous, and nurtures these qualities by employing people who share our passionate interest in making a difference in patients’ lives. We pride ourselves on a friendly, collaborative, open, dynamic and inclusive team, with a permanent focus on the why. 

The Role

We are seeking to appoint a Pharmacovigilance Associate on a permanent part-time basis (Mon-Fri, 4 hours per day). Reporting to the Pharmacovigilance Manager, you will be primarily responsible for safety activities for medicinal products in compliance with local regulations and company policies. Your key responsibilities will include:

• Accurate and timely processing, record keeping, regulatory reporting and follow-up of all incoming adverse events (AEs) for company products, in accordance with partner and regulatory requirements and ST procedures
• QA/QC of PV activities, including correct data entry, record keeping and periodic reconciliation of AEs and systems
• Notifying regulatory agencies and business partners accordingly and responding to requests from regulatory agencies 
• Assisting with the collection, analysis, local literature surveillance and reporting on local pharmacovigilance data for marketed products and products supplied under ST access programs
• Ensuring pharmacovigilance activities are fully compliant with company ST standard procedures and regulatory requirements
• Working collaboratively and liaising with internal and external stakeholders as appropriate, to ensure Pharmacovigilance obligations are met
• Performing internal and external reconciliation activities for ST products
• Supporting the Pharmacovigilance Manager with risk management activities
• Supporting audits, inspections and CAPA management as required 

What we are looking for

You will have:

• Diploma or Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, or Science majoring in Pharmacology or other relevant Medical / Health Sciences / Science
• Basic knowledge of Pharmacovigilance, pharmacology and the pharmaceutical industry
• Prior experience in a product / drug safety role within the pharmaceutical industry is desirable
• A well organised and customer-oriented approach
• Strong written and verbal communication skills 
• The ability to analyse and collate data
• Excellent attention to detail and sound time management skills with the ability to be flexible and meet conflicting deadlines 
• Excellent knowledge of MS Office and Mac systems
• Ability to work cross-functionally providing support to other departments as required 

What we offer you

This is an exciting opportunity to join a company with a growing product pipeline offering employees’ a culture of support, encouragement, passion and recognition.  We seek those who can bring a wealth of life experience and inspired ideas to our table.  In return, we provide an inclusive and flexible workplace environment that nurtures enduring professional relationships.  We provide wholesome remuneration packages with above average benefits including additional leave, medical insurance, a well-being grant and your birthday off!

Apply now!

If you are forward-thinking, dynamic in your outlook, and attracted to a challenge which is demanding and rewarding – this is your next step. 

ST is an equal opportunity workplace.  

This role is only open to candidates that have full eligibility to live and work in Singapore.