Senior Submissions Officer

• Supporting the client in all aspects of safety submission
• Supports the Submission Manager in development documentation implementation and maintenance of submission processes and standards
• Ensures personal knowledge and understanding of global regulatory reporting requirements to ensure compliance
• Performing submissions of ICSRs/aggregate reports to all concerned parties
• Performing exchanges of ICSRs with all concerned parties as per applicable documents
• Providing support in all PV operations associated with Safety Reporting
• Performing Quality control of ICSR Reportability Assessment
• Performing Quality control of daily safety submission activities
• Active participation in trainings maintenance and development of quality system documents for Safety Reporting area
• Provide training for junior members of the team
• Acts as an SME for Submissions in audits and inspections representing Submissions business processes and standards

Qualifications :

• Life science graduate pharmacy nursing or other healthcare related qualification
• 3-5 years of work experience in pharmacovigilance with at least 2 years of experience working on submissions
• Organization skills including attention to detail and multitasking
• Management skills including time and issue management
• Communication skills including clear and effective interaction with internal and external stakeholders

English - fluent (spoken written)

Additional Information :

Why PrimeVigilance

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