Drug Saftey Programming Specialist
Contract - 6 months
Outside IR35 Rate
- The PV Data Analyst in the Safety Analytics and Reporting (SAR) group of the Safety Risk Management function (PDS) is responsible to provide impactful safety data retrieval and reporting solutions to answer medical inquiries on the safety of our molecules.
- He/She also provides complex aggregate ad-hoc insight into the data flow of Individual Case Safety Reports (ICSR).
- He/She assumes responsibility for the analyses of individual Case Study Report (ICSR) data from the internal Drug Safety Database (Oracle DataMart, ARISg).
- The criticality of these deliverables (e.g. mandated from regulators) require that standards, timelines and needs from customers in Clinical Science, Affiliates, Regulatory and other functions are attained.
- The role combines a good understanding of Roche molecules, the ICSR processing workflow and a detailed understanding of the Pharmacovigilance data.
- A core part of the role consists in applying programming and data display expertise to provide meaningful insight on medical safety and ICSR processing data.
- For the implementation of analyses, he/she develops, tests, documents, maintains, verifies and/or validates analysis programs written in SQL, PL/SQL, SAS, as appropriate. Results of the analyses form a key component for a patient focused risk
- Responsible for individual PV Safety Data requests
- Advise the requester on the search and data display options
- Progress to a deep understanding of the Pharmacovigilance data and processes
- Produce high quality analyses ? ensure transparency, reproducibility and compliance with applicable procedures and standards
- Explain and share results, including assumptions, potential bias with requester
- Apply rigor in planning of data processing and presentation of results, design fit for purpose approaches
- Active contribution to knowledge sharing in the team
- Ensure any issues relating to data, programs or tools are adequately addressed at the lowest level and escalated appropriately
- Provide out of office hour support in unforeseen urgency and if declared accordingly by management.
- M.S. or advanced degree in Natural Sciences, Computer Science or other related quantitative field
- Knowledge of Pharmacovigilance data flow and rules from data entry to processing to analysis.
Experience, Skills, Knowledge:
- Essential programming skills to perform and handle large data volumes and relational data bases (e.g. SQL) as well as analysis display (e.g. R, SAS)
- Essential knowledge of pharmacovigilance processes and data parameters relevant in characterization of tolerability of pharmaceutical drugs as well as regulatory reporting requirements and their implementation.
- Ability to build collaborate with appropriate personnel in other functional groups within and outside of the Safety Risk Management (PDS) organization.
- Evidence of displaying an entrepreneurial mindset
- Ability to think analytically to transform data information questions into data retrieval and reporting strategies as well as implementing those successfully.
- Applied experience in visualization of data and analysis results.
- Strong communication skills in an international cross-functional environment with the ability to effectively explain data strategies, both verbally and in writing
For further details, please contact Rudo Urayayi on +44(0)1727 817 616 or email a copy of your CV to email@example.com
- Agency: Achieva Group Limited
- Reference: RU-47
Website: Achieva Group Limited
- Posted: 10th May 2022
- Expires: 7th June 2022