EU Qualified Person for Pharmacovigilance (QPPV) - Home based
- Experience Level
- Experienced (non-manager)
This position is available home based in Germany, Italy, Spain, France, the Netherlands and Norway.
This position is responsible for establishing and maintaining the Market Authorisation Holder/Applicant’s (MAH/MAA, referred to as the Client) Pharmacovigilance System, overseeing the global safety profile of the client’s products approved in Europe or in application, and acting as a single point of contact for the Regulatory Authorities on a full time, 24 hours/7 days a week basis.
- MD, PharmD, post graduate degree in a science or health-related field, pharmacy or nursing. If not medically qualified, shall have access to a designated medically qualified person.
- At least 8 years of experience in pharmacovigilance.
- Strong experience in pharmacovigilance in Pharmaceutical Companies, biotech or CRO.
- Deep knowledge of other aspects of product development and post marketing product management (e.g., regulatory, risk management, benefit risk, epidemiology, medical affairs).
- Excellent knowledge of pharmacovigilance regulations and legislation.
- Strong leadership, analytical, organizational skills.
- Strong written and verbal communication skills.
- Strong presentation skills.
- Strong interpersonal skills.
- Must be able to speak fluent English.
- Official full time residence and operates in the EU.
- Ability to travel from time to time to UBC locations, clients, and professional/scientific meetings.
- Oversees the nominated Local Qualified Persons for Pharmacovigilance / local Pharmacovigilance contact persons in European countries.
- Provides mentoring and training on Pharmacovigilance activities to PV and Operations Systems staff, as appropriate.
Specific Job Duties:
- Establishes and maintains/manages the Client’s PV system to ensure full compliance with all legal and regulatory requirements in the EU.
- Has an oversight of the Pharmacovigilance System Master File (PSMF) and its maintenance.
- Has an overview of the safety profiles and any emerging safety concerns in relation to the medicinal products for which the Client holds or has applied for authorizations in EU.
- Has an awareness of any conditions or obligations adopted as part of the marketing authorization and other commitments to safety or the safe use of the Client’s medicinal products.
- Acts as the main point of contact with the relevant Competent Authorities and is available to be contacted by them 24/7.
- Has an oversight of all aspects of the Client’s PV system. Can delegate tasks but maintains ultimate responsibility for PV activities including:
- Individual Case Safety Reports (ICSRs), Standard Operating Procedures (SOPs), Periodic Safety Update Reports (PSURs), Risk Management Plans (RMP), including review and approval, Post Authorization Safety Study (PASS) protocols, including review and approval, Risk Minimisation Strategies, effectiveness of follow-up measures, post-marketing commitments, the safety database, e-transmission and of findings / observations from Regulatory Authorities Inspections, QA/Client audits of PV activities and other safety-related audits.
- Ensures expedited and periodic submission of all PV-related documents in accordance with legal requirements and GVP.
- Reviews all PV training materials to ensure that they are correct and appropriate for purpose.
- Reviews and approves the content of the Safety Data Exchange Agreements between the client and its partners as required.
- Has an awareness of the validation status of the safety database, including any failures that occurred during validation and the corrective actions taken to address these failures.
- Ensures that local QPPV(s) are registered with the local Competent Authorities when required by the national law.
- Ensures that any requests coming from the Competent Authorities related to PV or safety matters are fulfilled.
- Informs deputy about any absence, and ensures that any urgent PV requests are correctly managed by a qualified person (deputy QPPV).
- Keeps up to date about the relevant regulations, legislation and literature of Pharmacovigilance, pharmacology and pharmacoepidemiology.
- Ensures full compliance of the MAH’s PV system with the European regulations.
- Liaises closely with clients, and represents UBC.
- Ensures that given timelines are met according to project and regulatory timelines.
- Provides input to safety, risk management and clinical documents.
- Provides input into the preparation of regulatory action in response to emerging safety concerns (including variations, urgent safety restrictions, and communications to consumers and healthcare professionals).
- Liaises closely with Quality Assurance to ensure full compliance of projects namely with regards to QPPV and PSMF.
- Supports regulatory inspections and actively participates in their preparation.
- Prepares, reviews and approves internal UBC PV SOPs and project specific procedures as required.
- Participates in relevant seminars and congresses (if requested).
- Supports the Executive Director, Global Head of PV.
- Leads or participates in Safety Committee meetings as required.
- Presents on behalf of UBC at PV conferences and meetings.
- Performs additional duties as assigned by UBC Senior Management.
United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety.
While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.
Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.
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