Description

Job Description

The Deputy Serbia Responsible Person for Pharmacovigilance (RPPV) ensures that all pharmacovigilance (PV) activities in Serbia are compliant with local PV regulations. The Serbia RPPV maintains currency with evolving local guidance and regulations for PV. This individual supports International PV to ensure GPS has standards and processes in place to meet PV requirements at the local level.

This is Maternity cover for 18 months with potential to extend.

KEY RESPONSIBILITIES:

Serve as Vertex's appointed Deputy Person Responsible for Pharmacovigilance (RPPV) located in Serbia, notified in writing to the Serbian Health Authorities;

Be continuously and permanently available to Serbian Health Authorities, acting as the primary PV point of contact between the Health Authority and Vertex for all PV activities on a 24-hour basis and also as a point of contact for PV inspections;

Be permanently and continuously available to respond to urgent PV inquiries and to make notifications, as necessary, to Serbia Health Authorities concerning medicinal product risks.

Ensure that additional information for the evaluation of the risk-benefit profile of a medicinal product is sent immediately and in full, if requested by the Health Authority;

Assist with communication of Special Circumstance Safety Information and product recalls as required or requested;

Maintain, on an ongoing basis, an up-to-date knowledge and thorough understanding of the local PV legislation as relevant to comply with the local PV obligations.

Perform regular local PV regulatory intelligence surveillance for any changes to the local PV requirements;

Perform and document local scientific and medical literature searches for potential Adverse Events and Other Safety Information as assigned;

Communicate immediately any suspected safety issues in the country as per applicable procedure;

Maintain up-to-date Curriculum Vitae and appropriate qualifications as required;

Maintain compliance with all applicable training requirements;

Be available to assist GPS Quality, Standards, and Training (QST) Team with PV audits/inspections and resulting Corrective Action /Preventative Action (CAPA), as requested;

Ensure the accurate and timely submission of Individual Case Safety Reports (ICSRs) to Serbian Health Authorities, including translation, transcription onto local form, and transmission as requested;

Provide input into the preparation of regulatory actions in response to emerging safety concerns (e.g., variations, urgent safety restrictions, and communication to patients and healthcare professionals);

Work in conjunction with GPS International PV Team to promote, maintain, and improve compliance with regulatory requirements;

Work in conjunction with GPS QST Team to maintain the Serbian Pharmacovigilance System Master File (PSMF);

Keeping up to date with product safety data generated as a result of post-authorization activities through access to systems and reports;

Maintain awareness of the safety profiles of Vertex products, as applicable;

Maintain awareness of risk minimization measures and the Risk Management Plan, as applicable;

Maintain awareness of periodic aggregate reports, as applicable;

Maintain all appropriate documentation to support procedures;

Triage and escalate patient safety related matters as appropriate;

Contribute to vendor oversight activities;

Research PV regulations and guidelines;

Review, assess, and track global PV regulatory intelligence;

Review PV agreements which support local and regional PV requirements;

Represent GPS and Vertex regarding patient safety related matters as assigned;

Be qualified to act as a Deputy to the Serbian Quality Responsible Person;

Support other PV activities in Serbia and outside as requested.

KEY REQUIREMENTS:

• Health care professional (degree in pharmacy, medicine, or dentistry)
• Strong knowledge and documentation of education in the field of Serbian pharmacovigilance regulations, standards, and best practices regarding safety processing and reporting, safety surveillance, and pharmaceutical industry compliance activities in the post-marketing approval setting
• Strong operational skills with proven track record working on ad hoc projects
• Excellent oral and written communication skills in English and Serbian
• High ethical standards, including a commitment to Vertex's values and behaviours
• Sound ability to communicate effectively in a matrix environment
• Ability to multi-task with sound attention to detail
• Strong sense of responsibility and an ability to work autonomously, as well as act as a strong team player
• Displays ability to understand established procedures and communicate those procedures to others.

Job is remote with the opportunity to come to the office.

Flex Designation:
Remote-Eligible

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Remote

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com