SENIOR SUBMISSIONS OFFICER
Ergomed
Full-timesenior
Job description
<ul><li>Supporting the client in all aspects of safety submission</li><li>Supports the Submission Manager in development, documentation, implementation and maintenance of submission processes and standards</li><li>Ensures personal knowledge and understanding of global regulatory reporting requirements to ensure compliance</li><li>Performing submissions of ICSRs/aggregate reports to all concerned parties</li><li>Performing exchanges of ICSRs with all concerned parties as per applicable documents</li><li>Providing support in all PV operations associated with Safety Reporting</li><li>Performing Quality control of ICSR Reportability Assessment</li><li>Performing Quality control of daily safety submission activities</li><li>Active participation in trainings, maintenance and development of quality system documents for Safety Reporting area</li><li>Provide training for junior members of the team</li><li>Acts as an SME for Submissions in audits and inspections representing Submissions business processes and standards</li></ul>
<ul><li>Life science graduate, pharmacy, nursing or other healthcare related qualification</li><li>3-5 years of work experience in pharmacovigilance with at least 2 years of experience working on submissions</li><li>Organization skills, including attention to detail and multitasking</li><li>Management skills, including time and issue management</li><li>Communication skills, including clear and effective interaction with internal and external stakeholders</li></ul><p>English - fluent (spoken, written)</p>
<p><strong>Why PrimeVigilance?</strong></p><p>When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.  </p><p>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. </p><ul><li><p>Quality: we hold ourselves to the standard patients deserve. </p></li></ul><ul><li><p>Integrity and trust: we do the right thing, especially when it is hard. </p></li></ul><ul><li><p>Drive and passion: we care about the outcome, because someone is waiting on it. </p></li></ul><ul><li><p>Agility and responsiveness: we move quickly, because patients cannot wait. </p></li></ul><ul><li><p>Belonging: everyone is welcome, and every voice counts. </p></li></ul><ul><li><p>Collaborative partnerships: we go further by going together. </p></li></ul><p>We look forward to welcoming your application. </p>