The Associate Director, Pharmacovigilance (PV) Agreements and Operations manages, and provides oversight for, the PV Agreements, Quality, standards, and training elements of the pharmacovigilance function. This includes, but may not be limited to, developing new, or revising existing, Standard Operating Procedures (SOPs)/processes to adhere to global pharmacovigilance regulations and requirements.
He/she also leads, and actively contributes to, the development or revision of existing processes related to, but which may not be limited to, the followng: Quality standards; Pharmacovigilance System Master File (PSMF) compilation; Safety Data Exchange Agreements (SDEAs); collection and reporting of safety data from clinical trials and post-marketing surveillance.
The incumbent works cross-functionally with internal departments/key stakeholders and external resources on pharmacovigilance-related matters.
The Associate Director, PV Agreements and Operations supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Develops, and is responsible for, all SDEAs or pharmacovigilance agreements with PTC partners and vendors for specific obligations for safety data exchange and reporting.
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 with, and collaborates with, EU and local Qualified Person (QP) to develop new or maintain existing pharmacovigilance processes supporting both development and marketed/commercial products.
Assists the EU QPPV in the compilation and Quality Control of the PSMF as well as supplying information relating to contracts and vendors.
Works closely with, 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 with, and collaborates with, Supply Chain and Commercial to ensure agreements are in place to support Individual Case Safety Reports (ICSR) reporting from global expansion programs.
Builds relationships with, 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.
Contributes to inspection readiness and leads, with the EU QPPV, Health Authority inspections of PTC’s pharmacovigilance function.
Supports the Head of PV with financial planning, raising purchase orders and budget control.
Performs other tasks and assignments as needed and specified by management.
May manage, coach and mentor direct reports.
BSN/RN, Bachelor’s degree in Biological Sciences, Pharmacy or PharmD degree and a minimum of 7 years progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology or related environment, at least 3 of which were spent in a leadership role within pharmacovigilance operations.
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 experience leading, and actively 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.
Ability to influence without direct authority.
Proficiency with Microsoft Office.
Excellent verbal and written communication 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.
Expertise in the use of Electronic Document Management System (eDMS) software preferred>
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.