Specialist, Local Regulatory and PV network

The RA & PV specialist will act as Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) and serves as the primary local RA&PV representative to ensure compliance with national pharmacovigilance and regulatory requirements in Australia. This position is responsible for executing PV and RA activities at the local level supporting the Marketing Authorisation Holder (MAH) in maintaining product compliance throughout its lifecycle. 

Main responsibilities

• Prompt and effective communication with MAH and local regulatory authorities as required
• Primary contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance as per local requirements
• Provision of local regulatory intelligence screening and expert advice for the responsible region(s)
• Collection and reporting of locally suspected ADRs or ICSRs (FUs translations)
• Local management / oversight of risk minimization measures related to urgent safety restrictions and emerging safety issues
• Support with development and implementation of local pharmacovigilance system in compliance with Global MAHs system and local regulations
• Perform local non-indexed literature screening and screening of regulatory authority website/s for potential Adverse Drug Reactions (ADRs) and safety information
• Maintain accurate records and documentation at local level
• Provide support to the RA & PV Global operations team
• Preparation and collection of documentation for submissions to the regulatory authorities
• Review and linguistic input on local Product Information and Mock-ups  
• Ensure compliance with MAHs and PrimeVigilances procedures
• Support audits and Inspections
• Handle local QA tasks such as suspected falsified products quality alerts received from health authorities and other quality-related requirements received from the local market

Qualifications :

• Bachelors Degree in Life Sciences or Chemistry Nursing or equivalent professional experience
• At least 3 years of pharmacovigilance or safety-related experience in pharmaceutical CRO or regulatory environment
• Good understanding of ICH GVP and local pharmacovigilance requirements (training or practical exposure)
• Experience in case handling literature screening or local PV activities is preferred
• Prior experience in Regulatory Affairs is preferred but not mandatory
• Proficiency in English and additional language knowledge is advantageous
• Strong skills in Microsoft Office applications including Word Excel and PowerPoint

Additional Information :

When you join Ergomed Group you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. Youll join a passionate and collaborative team of experts in clinical research pharmacovigilance and quality consulting.  

We are diverse in many ways yet our values unite us. Our values are how we work not words on a wall. If they sound like you you will feel at home here. 

• Quality: we hold ourselves to the standard patients deserve. 
• Integrity and trust: we do the right thing especially when it is hard. 
• Drive and passion: we care about the outcome because someone is waiting on it. 
• Agility and responsiveness: we move quickly because patients cannot wait. 
• Belonging: everyone is welcome and every voice counts. 
• Collaborative partnerships: we go further by going together. 

We look forward to welcoming your application. 

Remote Work :

Yes

Employment Type :

Full-time