6 Rmps Jobs

Company Description We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and becoming one of the global leaders in its fields. We cover all therapy areas including medical devices. We love investing in our staff by providing an excell...

Role Overview: You will be responsible for ensuring the safety and effectiveness of pharmaceuticals through signal detection, risk management, and regulatory compliance. This includes preparing and reviewing Risk Management Plans (RMPs), aggregate reports, and signal detection reports. Your role will also involve training, authoring SOPs/WIs, and ensuring compliance with Good Pharmacovigilance Practices. Key Responsibilities: - Signal Detection and management - Drafting or reviewing signal detection reports - Preparation and review of Risk Management Plans (RMP) - Preparation and review of Risk Management Plan aggregate reports (PADERs/PSURs) - Handling additional Risk Minimization Measures ...

Responsible for handling end to end Case management (ICSRs) activities and to ensure the compliance. Manage assigned team and ensure that all tasks are performed according to guidelines and standard operating procedures. Consulting and guiding the pharmacovigilance team for completion of aggregate reports (PSURs, PADERs, RMPs and applicable regulatory submission PV documents) as required for regulatory submission To develop and review pharmacovigilance SOPs. Coordination with MICC for ICSR activities and regulatory compliance. Coordinating the safety data exchange agreements between Hetero and business partners. Responsible for providing guidance and training to team as and when required. Re...

Company Description We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device. We love investing in our staff by providing an excellent traini...

Job Insights: Our client is seeking an ambitious and energetic Medical Writer for the authoring of aggregate safety reports to join their Safety team Responsibilities: Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations. Responsible for end-to-end authoring of complex deliverables - periodic aggregate reports, including PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports, send documents for review on a timely manner, liaise with subject specific stakeholders, set up review comments resolution meetings when needed, facilitate QC process, referen...

Level A4 – 3+ years Associate - Scientific Writing_Aggregate reporting Locations – across any nodal offices/Hybrid **Job Description:** **Responsibilities:** - Responsible for the entire document life cycle, maintaining quality, timeliness, and compliance with internal/client SOPs and regulations. - End-to-end authoring of complex deliverables - periodic aggregate reports, including PBRERs, PSURs, SUSAR, PADERs/PAERs, ACOs, RMPs , and ad-hoc regulatory and safety reports. - Perform QC review of documents to validate accuracy and relevance, ensuring compliance with client-specific style and global standards. - Assist and mentor junior writers, provide guidance, and ensure consistency and comp...