Job Description: Responsibilities of the role include: Compiles and authors the PSMF, working with contributors to improve the quality and accuracy of the annexes.
Track and document all of the country specific PSMFs ensuring all national requirements are met.
Authors and updates all SDEAs or pharmacovigilance agreements with PTC partners and vendors for specific obligations for safety data exchange and reporting.
Builds relationships, and collaborates with, Supply Chain and Commercial to ensure Agreements are in place to support ICSR reporting from global expansion programs.
Implements/applies Quality Management System as it relates to the pharmacovigilance function.
This includes compliance reporting, compliance monitoring and developing new, or revising existing, SOPs/processes as needed.
Works closely and collaborates with EU and local Qualified Person (QP) to develop new or maintain existing pharmacovigilance processes supporting both development and marketed/commercial products.
Works closely and collaborates with PV department members to develop, and actively contribute to relevant pharmacovigilance processes and templates.
Ensures key PV documents and templates are managed and retained in the appropriate electronic system e.g. Sharepoint, Legal and Regulatory electronic filing systems.
Builds relationships, and collaborates with, the Quality department to ensure appropriate processes are in place for inspection readiness.
This includes, but may not be limited to, leading pharmacovigilance audit responses, developing and managing corrective action plans, etc.
Ensures essential documentation is in place as part of Inspection Readiness Contributes to inspection readiness and leads, with the EU QPPV, HA inspections of PTC's pharmacovigilance function.
Performs other tasks and assignments as needed and specified by management.
Requirements for the role include: BSN/RN, Bachelor's degree or higher in Pharmacy or Life Sciences and a minimum of 4 + years progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology or related environment.
Demonstrated expert knowledge of relevant Food and Drug Administration (FDA), European Union (EU) and International Conference on Harmonisation (ICH) guidelines, initiatives, and regulations governing pharmacovigilance.
Demonstrated expertise in authoring and compiling PSMFs.
Previous experience of performing the duties of the EU deputy QPPV desirable.
Demonstrated experience leading and contributing to process improvements, quality management system, inspection readiness, Health Authority audits, standardization of safety reports, SDEA negotiations, vendor management, etc Extensive working knowledge of medical terminology and Medical Dictionary of Regulatory Activities (MedDRA).
Demonstrated hands-on experience identifying, developing and implementing improvements to departmental processes that increase efficiency and maintain or improve quality.
Proficiency with Microsoft Office, Sharepoint and excellent verbal and written communication and skills.
Ability to work independently and collaboratively, as required, in a fast-paced matrixed team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.