Our client, a worldwide pharmaceutical company, is looking for 2 Country Safety Heads (CSH) to come on board and join their team. Each Country Safety Head will be responsible for one of the following countries : Switzerland or Austria.
Job Description
The CSH will serve as the local PV contact for the authorities, accountable for PV inspections and is nominated as local Responsible Person for Pharmacovigilance (RPP/QPPV) for the CHC products where applicable per national regulations.
The CSH is recognized as the key leader for all PV related activities at country level, including but not limited to case management, local safety surveillance, signal detection, risk management and risk mitigation activities, patient support programs and market research programs for PV aspects.
He/She will ensure that local PV activities are performed in compliance with the Global PV policies, as well as global, regional, and local PV regulations to warrant safe and appropriate use of CHC products on the market in the assigned country.
The CSH establishes and maintains robust and efficient local PV systems in
the designated country by ensuring the availability and implementation of proper systems/procedures, tools and training.
The CSH supports the QPPV in overseeing the PV activities in the country and the CHC Head of Safety with regards to local budget planning and management. He/She builds close and robust relations/collaboration with the in-country partner functions, including but not limited to Medical, Regulatory, Quality, Commercial, Legal, and Country Manager.
He/She acts as Deputy CSH for a partner country and reports to PV Zone Head with dotted line to Country Manager.
Responsibilities
Local Partnership
- Represent PV in interactions with local GxP and non GxP functions, to optimize coordination and collaboration in areas of overlapping interests
- Build and maintain robust collaboration/interaction with the in-country partner functions, to carry out and monitor local PV activities, in compliance with PV regulatory requirements and company procedures/guidelines, and particularly,
- Build and maintain robust working relationship with local external PV vendors as well as Global PV vendors operating local activities
Global Partnership
- Identify issues or dysfunction in the assigned country(ies) and escalate to senior PV Management,
- In case of local PV outsourcing activities, collaborate with Global PV to implement the best outsourced capabilities
- Interact with Global PV for any questions related to the safety profile of CHC products originating from HA or any other sources
Organization and maintenance of local PV Quality system
- Establish and implement processes in compliance with regional/local PV regulations and global procedures and cooperate with the local Quality Head to document them in local Quality Documents as appropriate
- Ensure maintenance of local quality documents owned by PV to include documented reviews, gap assessments and revisions as per global requirements
- Develop and maintain the local PV System Master File in accordance with the global standards
- Ensure that education and training on PV and relevant safety topics within the local organization are performed including documentation of attendees and topics covered (i.e. PV Awareness, training of service providers and manufacturing sites)
- Manage local compliance metrics generation and ensure data capture in the appropriate tools
- Document PV process non-compliance to include investigation, Root Cause Analysis (RCA), Corrective Actions/Preventive Actions (CAPAs) implementation and coordinate related tracking activities with local Quality Head
- Warrant audit and inspection readiness of the local PV system (auditable trail of all PV activities performed locally is maintained and readily available) with key stakeholders (i.e. Quality, Medical, Regulatory)
- Complete in timely manner audit and inspection observations in close interaction with
Organization and Maintenance of PV Operating & Safety Management System
- In compliance with PV regulatory requirements and company procedures/guidelines, monitor continuously in-coming communication to ensure the detection and appropriate management of in-coming PV data (ICSRs and other safety related information) to report them in timely manner to Global PV Operations and subsequently to external stakeholders, such as HAs, partners
- Handle appropriately local periodic reports, including periodic safety reports (PSRs) and periodic reviews, and contribute together with Global PV, Clinical Operations and RA departments to the planning for PSRs
- Ensure screening of local scientific / medical literature and management of relevant abstract/articles
- Ensure appropriate implementation and monitoring of PV requirements for global, regional and local programs (e.g. Patient Support Program, Market Research, Managed Access Program etc), and company sponsored digital media
- Ensure screening and analysis of national regulations, and forward any future/new/updated PV regulation as per defined processes
- Secure that for all global/local Business Partner agreements, requiring safety provisions, a local SDEA or PV Clause is set-up, implemented and maintained as appropriate
- In case of local outsourcing of PV activities to third parties (i.e. vendors/service providers/CROs), Manage contract/work order with local service provider, monitor the appropriate execution of outsourced activities and take the appropriate measures in case of deviations
- Support the Global PV and particularly the QPPV with local safety surveillance activities
- Handle/escalate product safety alerts in timely manner
- Contribute to the development of local RMP, when applicable, with the support and validation of the Risk Management Expert. Track the actual implementation of additional Risk Minimization Measures (aRMMs) in the assigned country
- Ensure that PV unit is involved in reviewing relevant safety sections of local documents, owned by other affiliates entities, such as labelling, contracts with third parties and local study protocols
Requirements
- University in Health Sciences
- Min. 3 years experience in Pharmacovigilance/Drug Safety
- Appropriate experience with Regulatory Agency interactions
- Knowledge of national PV regulations and international regulations regarding safety requirements as well as industry standards
- Good level of speaking/writing English and German
- Good written and verbal communication skills
- Pragmatic, solution oriented mindset
- Problem-solving, prioritize
- Take initiative and meet challenge
Benefits/contract information
- Start Date: ASAP
- Full-time
- 1 year contract, possibility of extension
- Fully remote position with potential ad hoc travel
Vacancy number: 23895
