Details
Purpose of Job
- Provide the company and all representatives, clients, and customers with competent and knowledgeable support in maintaining and fulfilling all pharmacovigilance responsibilities in accordance with current legislation and internal applicable processes.
- To work cross-functionally within the company, providing PV support and training to other functions as required, and medical and technical support in both medical information and pharmacovigilance.
- To assist the company and clients on a daily basis, to ensure all pharmacovigilance responsibilities are fulfilled in accordance with current legislation and company guidelines
- Support the EEA QPPV and PV team in the execution of high-quality and robust pharmacovigilance activities.
- Act as National Contact Person for assigned clients, supporting local pharmacovigilance oversight, regulatory authority interactions and compliance activities in accordance with client agreements and applicable legislation.
Qualifications and Role Requirements
- Life science degree, preferably within the sphere of pharmacy, medicine, or veterinary
medicine, chemistry, pharmaceutical chemistry and technology or biology.
- A minimum of 5 years of pharmaceutical industry experience.
- Relevant proven pharmacovigilance experience.
- Experience with medical information.
- Experience with managing or monitoring clinical trials.
- Awareness of benefit/risk assessment in patient safety.
Personal Attributes
- Ability to solve routine problems and to manage issues constructively.
- Ability to act autonomously where appropriate, take initiatives and make decisions with a clear understanding of the consequences and potential next steps.
- Ability to communicate effectively, conveying concise and meaningful information to support actions, decisions, and proposals.
- Attention to detail.
- Ability to work cross-functionally with all company departments and clients practically apply pharmacovigilance/medical information and associated legislation.
- Have skills for the management of pharmacovigilance systems, in particular when acting as the company-nominated NCP for PV or QPPV.
Relevant Regulation and Related Issues
- Directive 2001/83/EC
- Regulation (EC) No 726/2004
- Regulation (EC) No 520/2012
- Commission Implementing Regulation on the Performance of Pharmacovigilance Activities Provided for in Regulation (EC) No 726/2004 and Directive 2001/83/EC
- Guideline on good pharmacovigilance practice modules
- Human Medicines Regulations 2012 and Statutory Instruments.
- Data protection legislation.
Relationships
- Responsibility to:
- Associate Director, Pharmacovigilance
- Direct relationships:
- EEA QPPV
- Pharmacovigilance Team
- Regulatory and other technical staff
- regenold UK and IE staff
- External customers
- Competent Regulatory Authorities
- External consultants and contractors
Indirect relationships: Other members of regenold staff and company clients and partners
Limits of Role
The post holder is not expected to authorise expenditure. If required, this will be in agreement with the Associate Director, Pharmacovigilance.
Main Duties and Responsibilities
Pharmacovigilance Activities
- Contribute to the compilation of the company and client Pharmacovigilance System Master Files and associated Annexes.
- Provide cross-functional liaison to support other departments in relation to handling safety information.
- Support the company in all internal and external audit activities, including contributing to an appropriate audit strategy and participating in client and company audits. Participate in inspection readiness activities.
- Support the company in all activities resulting from external audits and inspections, including close-out activities and corrective and preventative actions.
- Conduct daily PV activities to ensure all data is retrieved from various sources, including Competent Authority portals and literature search facilities
- Conduct data entry to the various monitoring systems and company global safety database to ensure accurate retrieval of safety data for periodic reporting
- Review literature search strategies in collaboration with the medical expert and QPPVs
- Work collaboratively with the assigned medical experts, Regulatory team and QPPVs to contribute to the management, scheduling, content of Risk Management Plans (RMPs).
- Work collaboratively with the assigned medical experts, regulatory team and QPPVs to contribute to the management, scheduling, content and review of periodic reports such as DSURs/PSURs/PBRERs.
- Manage project-specific review of cumulative safety data for signal review and have an awareness of the relevant product information to ensure appropriate assessment and escalation of safety concerns, identifying risk and collaborating with the stakeholders, clients, medical experts and QPPVs for any further actions.
- Liaise with company partners to ensure establishment of a safety data exchange agreement and compliance in exchange for safety information.
- Liaise with the company medical expert on PV activities as appropriate.
- Provide appropriate training in pharmacovigilance and handling safety information to the company and clients.
- Contribute to data input into XEVMPD according to legislation and company requirements.
Support the QPPV in execution of oversight activities by:
- Documenting compliance checks,
- Ensuring the pharmacovigilance system master file is an accurate and up-to-date reflection of the Company’s (or client’s) pharmacovigilance system and pharmacovigilance metrics are recorded appropriately.
- Act as a source of pharmacovigilance expertise for the Company in meetings, for other functional departments, and in the absence of the QPPV.
- Ensure all communications received by pharmacovigilance from regulatory agencies (e.g., MHRA) are answered in a complete and timely manner and distributed promptly to the appropriate stakeholder.
- Support the QPPV in identification of emerging safety concerns and handling follow up actions.
- Provide appropriate training in Pharmacovigilance and handling safety information to the Company and clients.
- Review safety data for accuracy and completeness in the absence of the QPPV.
Medical Information and Regulatory Affairs
- Be the first point of contact for receipt of medical information enquiries via telephone, email, or letter.
- Ensure the 24-hour helpline is functioning and managed appropriately.
- Ensure that the medical information in box is monitored regularly, and that all enquiries are dealt with appropriately and according to internal procedures.
- Inform management of important safety issues as they arise which require attention.
- Provide a response to medical information enquiries using appropriate documented sources of information or approved published literature.
- Log, track and monitor enquiries for trends.
- Provide summary data for QPPV and Company (MAH) oversight, including attendance at monthly client teleconference as appropriate.
- Support the Associate Director, Pharmacovigilance, in the preparation and update of Medical Information SOPs and guidance documents.
- Ensure that all FAQ sheets/reference documents are kept up to date.
- Support management in training new starters on how to manage medical information requests and in the provision of annual refresher training.
General responsibilities
Develop and preserve expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database.
Understand the nature and importance of PV compliance metrics QPPV oversight.
All employees of regenold UK & IE Ltd have a responsibility under the Health and Safety at Work etc Act 1974 to ensure their own and other’s safety whilst at work and to be aware and work within the framework of regenold UK & IE’s Health and Safety Policy and the associated Standard Operating Procedures.
Benefits
We offer a competitive salary in accordance with experience and a desirable employee benefits package including:
- 30 days holiday plus bank holidays and the option to purchase additional holiday
- Company pension
- Healthcare
- Discretionary annual profit-based bonus
- Flexible working options
- Enhanced maternity pay, subject to qualifying criteria
- Employee Assistance Programme
- Mental Health First Aiders
- Cycle and Tech Schemes
- Up to 15 hours per year to spend volunteering
Internal and external training will be provided along with coaching and mentoring, and there will be opportunities to develop your career within the business. We also have opportunities across the organisation to get involved in contributing to other areas that you have a passion for such as marketing or wellbeing.
