Drug Safety / Pharmacovigilance System Specialist

MAIN RESPONSIBILITIES

• Responsible for overseeing outsourced activities of vendors daily
• Responsible for ensuring Safety Systems processes are documented and identifying and documenting new processes as required.
• Ensure outsourced vendors are trained on relevant processes.
• Ensure that all requests to Safety Systems are triaged and actioned on time by the outsourced vendors.
• Ensure all data configured in the PV Safety Database is up to date and accurate. 
• Ensure (in conjunction with outsourced vendors) all appropriate data and reports are available for all stakeholders and customers (metrics, compliance data etc.)
• Work with internal IT Department and Outsourced Vendors to resolve any system issues or access issues.
• Proactively identify process improvements where Safety Systems team (including outsourced vendors) are interacting with other departments or outsourced vendors.
• Support the PV Systems Lead in additional activities such as Database updates, implementation of new functionality, new systems or re-versioning of processes.

KEY REQUIREMENTS

• Advanced knowledge of Argus database including Console configuration.
• Knowledge of Cognos BI or similar is preferred.
• SQL Developer skills are preferred.
• Knowledge of PV regulatory requirements coupled with IT skills to provide technical and systems support.  
• Understanding of working processes, roles, and functions within a PV/Drug Safety environment
• Experience in contributing in IT projects managing changes to technical systems
• Strong ownership and problem-solving skills.
• Excellent collaborator with ability to partner effectively with both IT and business/non-technical customers and stakeholders
• Ability to work independently whilst reporting into the PV Systems Lead.

LOCATION

Switzerland – Home or office based (depends on candidate personal preference)

DURATION

Full-time, permanent

SALARY

Attractive package with competitive benefits

ABOUT PLANET PHARMA

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com

TO APPLY

• If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0)203 868 8607 or e-mail on schapple@planet-pharma.co.uk
• If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!