The Senior Safety Manager, PV Operations (PVOps) is responsible for the management of the Poland PV Ops group within TFS Safety. This includes line management of Poland PV Ops staff and ensuring the PV Ops group works according to regulatory requirements and guidelines through the implementation and maintenance of applicable Standard Operating Procedures (SOPs) and Working Instructions (WIs). This role is a senior role within the department and reports direct to the Head of Global PV Operations.
- Overall responsibility for the management and leadership of the Poland PV Ops group within global PV Ops. Responsibilities of the PV Ops group span both clinical trials and post marketing and include, but are not limited to: Case (ADR/SAE) intake, triage, processing, QC & reconciliation, safety database management, medical information requests, XEVMPD management, literature screening, ICSR downloads, expedited reporting and submissions.
- Line manage staff global within the Poland PV Ops group.
- Author SOPs and WIs relevant to activities within the responsibility of the Poland PV Ops group and/or assign SOP and WIs authors accordingly.
- Ensure that new processes are implemented within the unit.
- Perform the operational activities of the SCM group if, and as, required.
- Maintain oversight of activities performed within the SCM group and support the preparation of metrics and key performance indicators.
- ·Contribute to the development of project-specific procedures (e.g. Pharmacovigilance Working Agreements) as applicable and as relevant to PV Ops activities.
- Provide support and guidance to staff in relation to PV Ops group activities.
- Oversee that delivery of PV Ops activities are performed in accordance with legal requirements, client contracts and relevant SOPs, WIs and project-specific procedures and within agreed budget.
- Lead relevant groups/meetings.
- Coach, support and mentor staff
- Initiate and lead internal improvement project with other relevant departments.
- Proactively identify improvements within both TFS Safety and the PV Ops group in order to improve quality, compliance and efficiency
- Actively contribute to the organization and development of routines/processes to enhance the work at TFS.
- Be well-informed and updated on regulations, directives and guidelines concerning activities within the responsibility of the PV Ops group.
- Oversees the validation of computer applications specific for the department with respect to drug safety requirements.
- Responsible for the updates of templates for safety handling in specific studies/projects according to relevant SOPs.
- Bachelor’s Degree, preferably in life science or nursing; or equivalent.
- 10 years of relevant experience.
- Able to work in a fast-paced environment with changing priorities.
- Understand the medical terminology and science associated with the assigned drugs and therapeutic areas.
- Understanding of GxP requirements, including Good Pharmacovigilance Practice (GVP) and
- Good Clinical Practice (GCP), ICH guidelines, other pharmacovigilance legislation and internal Policies, SOPs and WIs.
- Ability to work independently as well as in a team matrix organization with little or no supervision.
- Excellent written and verbal communication skills.
- Demonstrate proficiency using typical word processing; spreadsheets desirable; and presentation software a plus.
- Demonstrate ability to lead, mentor, educate and supervise Drug Safety personnel
- Additional 5 days paid vacation per year, in accordance with the Company’s vacation policy
- Private Health Coverage
- Global General Liability Insurance
- Global Travel Insurance
- Lunch allowance for office based employees