Leadership and management
- Build and maintain effective business relationships across the affiliate to support the implementation of patient safety standards.
- Maintain an environment of continuous improvement to optimize the affiliate PV system and contribute to regional and global process improvement initiatives, working with PPS subject matter experts.
Oversight of the Pharmacovigilance System
- Maintain oversight of affiliate PV compliance status, including the compliance status of outsourcing vendor, and actively monitor PV workload and resources.
- Escalate compliance issues and potential PV resource issues in a timely manner to the Affiliate Medical Director and IPEx/Vendor Management Team – Affiliate (VMT-A) to ensure appropriate mitigation.
- Maintain awareness and monitor local post-marketing and clinical PV legislation, to ensure PV legislation changes are communicated to relevant stakeholders for review, impact assessment, implementation and mitigation according to global procedures.
Quality Management System
- Ensure the Affiliate PV System procedure(s) aligns with corporate PV procedures and complies with local and regional PV regulations.
- Manage any non-conformity and/or planned departures from corporate and/or local PV procedures according to the global issue and exception management process and ensure any corrective/preventive actions are completed according to the schedule.
- Oversee the PV training plan and ensure training compliance of local PV personnel and other affiliate personnel with Corporate and Local PV training requirements.
- Oversee training compliance of partner company staff according to local contract requirements.
Adverse Event & Periodic Safety Reporting
- Ensure that processes, procedures and systems are in place for intake, processing, conducting follow up, translating and reconciling adverse events and other safety information reportable to PPS from spontaneous and solicited sources and from clinical studies.
- Ensure reporting of both clinical and post-marketing Individual Case Safety Reports (ICSRs) and Periodic and Aggregate Reports to the Regulatory Agency, Ethics Committees and Investigators, to comply with corporate PV procedures and with local and regional PV regulations as required.
Partnership with business partner with possibility for identification and/or handling of safety information
- Partner with Program Owners and commercial leaders to ensure that all business partnerships involving activities where there is a reasonable possibility for the identification and/or handling of safety information are assessed for the generation of safety information and the applicable PV requirements are applied in accordance with procedures and local requirements.
Safety Data Exchange Agreements (SDEA) and other PV Agreements:
- Ensure the content of local SDEAs and other PV agreements conforms procedures and local requirements and maintains the inventory in the PPS PV Agreements Database.
- Maintain and monitor compliance with local agreements.
Audits and Inspections
- Act as the key Affiliate contact for both internal PV audits and Regulatory Agency PV inspections.
- Ensure that any audit/inspection responses/corrective actions are completed according to the schedule.
- Support local QA and R&D PV QA to conduct vendor audits and complete vendor corrective action plans.
- As a member of the Affiliate Risk Management Team (ARMT), review Risk Management Plans (RMPs) and implement risk minimization measures at the affiliate according to procedures and local requirements.
- Understand the RMPs and information on the benefit/risk profile of products applicable for the Affiliate.
- Ensure the appropriate development and revision of Local RMPs and/or Country Specific Annexes, if applicable, liaising with ARMT & Benefit Risk Management (BRM) Team during development and revision of local documents.
- Partner with ARMT & Benefit Risk Management (BRM) Team during development or revision of the Local Implementation Plan (LIP) & local additional risk minimization measures.
- Maintain overview of medicinal product safety profiles and any emerging safety concerns for company products marketed within the relevant jurisdiction, and awareness of conditions or obligations adopted as part of the marketing authorizations, commitments relating to safety or the safe use of the products and of post-authorization safety studies requested by a regulatory agency.
- Understand and monitor incoming local safety data and communicate changes or potential concerns to the PPS Product Safety Team Lead and the EU QPPV (for products marketed in the EEA) for evaluation.
- Ensure a full and prompt response to regulatory agency requests for provision of additional information necessary for the benefit-risk evaluation of a medicinal product.
After Hours Availability & Business Continuity
- Ensure that an after-hours process is in place for the reporting of AEs.
- Ensure that a Disaster Recovery Plan/Business Continuity Plan is established in a risk-based manner to allow for continuation of critical business processes for PV.
INTERNAL/EXTERNAL CONTACTS AND INTERACTIONS
- Affiliate medical, regulatory affairs, clinical, quality assurance and customer service personnel.
- Affiliate Marketing, Sales and Operations personnel to ensure that all employees are trained and understand their responsibilities for reporting of any safety information.
- National Regulatory Agency responsible for product safety.
- Pharmacovigilance and Patient Safety, including but not limited to IPEx, Area PV Product Lead, Benefit-Risk Management and QPPV Office.
- Healthcare Practitioners, consumers and patients.
AUTHORITY AND REPORTING LINES
- This position reports into the PV Manager (into Affiliate Medical Director in absence of the ASR?).
- For all PV-related matters this position has additionally a dotted-line indirect reporting relationship to the EU QPPV.
- Medical, pharmacy or life-sciences degree (or equivalent).
- At least two years’ experience working in the pharmaceutical industry in a pharmacovigilance role is required.
- Excellent written and spoken communication and presentation skills.
- Fluency in written and oral English is essential to facilitate communications with Pharmacovigilance and Patient Safety, Area/Regional Medical and other headquarters functions.
- Fluency in written and oral local language is a requirement to facilitate communications within the affiliate medical department, and with the National Regulatory Agency.
- High customer orientation.
- Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity.
- Sound judgment, strong planning and organizational skills, and the ability to get things done. Demonstrated strong sense of urgency.
- Builds and maintains strong relationships with affiliate colleagues (e.g. Medical Affairs, Regulatory Affairs, Commercial) and PPS and tailors communication to different stakeholders to enhance understanding of PV requirements and elevate the PV internal brand.
- Learns fast, grasps the “essence”, ability to manage complexity and changes to change course quickly where indicated to add value to the PV system.
- Acts consistently with ethics, obligations and local laws – putting patient safety, partnerships and overall interests before individual, immediate team and functional interests.
- Focused on compliance; identifies, manages and escalates issues in a timely manner.
- Strengthens the use of product safety knowledge and channels scientific safety evidence and benefit-risk information to area and affiliate stakeholders to positively impact business strategies.