Pharmacovigilance Contractor (12 Months) in Craigavon

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease. At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

PTC is an established global biopharmaceutical company that delivers transformative therapies for people living with rare diseases. Patients are our priority; everything we’ve done, every study, every experiment, every investment is made first and foremost to change the course of rare diseases for the lives of our patients. We are on an exciting journey working to change patients’ lives every single day. We are motivated by our patients and the drive for them to have more moments with their families, made possible in part by our research and therapies.

The QPPV Office Pharmacovigilance contractor assists with compiling and authoring of the Pharmacovigilance System Master File (PSMF) and authors/revises Pharmacovigilance Agreements and Safety Data Exchange Agreements. The QPPV Office PV Contractor may also act as the deputy Qualified Person for Pharmacovigilance Europe and will support the QPPV office in relevant activities. The role will support the EU QPPV and the Associate Director PV. The PV contractor works cross-functionally with internal departments/key stakeholders and external resources on pharmacovigilance-related matters.

Responsibilities of the role:

• Compiles and authors the PSMF, working with contributors to improve the quality and accuracy of the annexes.
• Tracks and documents 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.
• 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.
• 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.
• 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:

• 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 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.

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, colour, 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.