Total 6 job vacancies by Ergomed

For the Client:

• To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. The review includes coding, seriousness assessment, Company causality and comment, listedness/expectedness and follow-up questions.
• To act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues
• To review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, literature screening search strategy
• To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings
• To cooperate in the preparation of and provide input in Risk Management Plans
• Supporting the preparation of responses to regulatory authority requests
• Signalling
• Reviewing line listings
• Participating in signal detection activities including meetings, writing signal detection reports if applicable if required, and providing consultation to clients on aspects related to benefit/risk assessment and risk minimisation
• Evaluating and categorizing possible signals and proposing a course of action
• Supporting preparation and review of benefit-risk reports

For the Client (may include but is not limited to the following):

• To review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. Review includes coding, assessment of seriousness, listedness/expectedness and Company causality, as well as writing of Company comment, follow-up questions and Analysis of Similar Events, when required. Including completion of all required supporting documentation such as trackers.
• To support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues
• To review and provide input in periodic reports
• To review literature screening search strategy
• To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings
• Reviewing database outputs
• Can be delegated to support signal detection activities upon acquiring sufficient experience
• Proposing a course of action whenever a new risk is identified

PrimeVigilance is looking for a Medical Information Associate to be responsible for supporting the Medical Information team in handling initial adverse event and medical information inquiries in English.  

Responsibilities 

• To provide approved responses to medical enquiries (healthcare professionals, patients, pharmaceutical clients) including call handling  
• To accurately identify, document and report adverse events/side effects, pregnancy and other special situation events, and product quality complaints within required timeframes 
• To ensure that all medical information enquiries are tracked and fully documented within the Medical Information database accurately and completely 
• To participate in the out-of-hours provision of medical information for clients who have contracted a 24/7 enquiry handling service 
•  Providing management with regular updates regarding project status and metrics concerning enquiries 
• Assisting in departmental regulatory inspection preparedness for the company pharmacovigilance system and actively participating in PV inspections or audits;  

POSITION SUMMARY:

• Responsible for Business Intelligence – development, deployment and maintenance of various business reports using business intelligence tools OAS.  
• Capability to develop scripts for report validation and data verification. 
• Contributes to achieving company´s goals and objectives. 
• Works independently. 

CORE RESPONSIBILITIES: 

• Develop, deploy, and maintain business intelligence reports using BI tools such as Oracle Analytics Server and Oracle BI Publisher. 
• Perform comprehensive testing and validation of custom BI reports to ensure data accuracy, system performance, and compliance with business and regulatory requirements. 
• Manage periodic and aggregate reporting activities, including oversight and/or execution of database reports and outputs. 
• Implement and maintain data quality management processes to ensure data integrity, consistency, and suitability for reliable reporting and analytics. 
• Provide support for database setup and configuration in collaboration with IT and safety systems teams. 
• Assist in the validation of computerized systems to ensure compliance with organizational and regulatory requirements. 
• Support data migration activities between databases while ensuring data integrity and accuracy. 
• Experience working with multi-tenant systems and database architectures supporting multiple clients or environments. 
• Prepare and maintain controlled documentation related to data management and database processes. 
• Manage and maintain long-term client engagements, ensuring effective communication and delivery of reporting and data management services.

SPECIAL SKILLS:

• Experience working with multi-tenant systems and database architectures supporting multiple clients or environments. 
• Validation/ UAT scripts development. 
• Back-end and application knowledge of Argus. 
• Strong SQL and PLSQL skills.

LANGUAGE SKILLS: Proficient in English 

We are looking for a pharmacovigilance medical writer to join our team. The  Medical Writer will be responsible for medical writing including:

• PSURs/PBRERs
• PADERs
• ACOs
• DSURs
• RMPs
• QC and review of all written output from the operations team as required
• Supporting the project managers to determine scheduling of the aggregate reports for which they are responsible
• In conjunction with the Quality, Compliance and Training Manager identify areas for improvement and address via training, clarifying changes to SOPs/OGs/templates
• Complete quality documentation of aggregate reports
• Attending kick off meetings with new clients as required
• Attending audits and inspections as required
• Providing aggregate report training

• The Lead Data Manager (LDM) within the ERGOMED Data Management (DM) department is responsible for providing oversight of all DM parts of a project from study start-up to database lock by working in a collaborative team environment with all functional groups.
• The Lead Data Manager represents a position under direction of the Director of Data Management.
• Provide updates for Data Management during internal/client team meetings and communication if required.
• Provides metric reports for internal/external project team
• Meets with the Project Manager to work on completing the study objectives in a timely manner
• Provides training of other DM staff on project specific processes
• Provides feedback to other project team members and managers to improve the deliverables
• Authors or reviews data management documentation including the Data Management Plan,
• Data Review Plan, eCRF Completion Guidelines, and others as needed
• Supports build, design and testing of EDC study designs
• Creates listings/reports using ad hoc reporting tools across multiple EDC systems
• Communicates any project risks or possible quality issues to the Project Manager
• May work on projects across multiple trial EDC platforms
• Maintains project files and ensures full traceability of all processes and documentation
• Manages Lab ranges across the entire study
• Performs data management activities such as data review, serious adverse event reconciliation, third party electronic data (e.g. laboratory, PK, diary) reconciliation, and query management
• Oversees the issuing of queries and reviews query responses with the highest level of quality
• Perform DM and/or EDC activities if needed, provided the required experience and background are in place