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- Full Time
Team Horizon currently has an exciting opening for a QPPV/Team Lead to work on our client’s manufacturing facility in the midlands. In your new role, you will look after the establishment and maintenance of the marketing authorisation holder’s pharmacovigilance system and therefore shall have sufficient authority to influence the performance of the quality system and the pharmacovigilance activities and to promote, maintain and improve compliance with the legal requirements.
Why you should apply:
- The company manufacturers and distributers for speciality off-patent/generic pharmaceuticals across the UK, Ireland and international markets
- Our client’s portfolio of products is diversified across multiple therapeutic areas, with particular strengths in analgesics and anti-infectives.
- Our client’s portfolio contains mainly niche, value-added products, which are complex to manufacture.
- With a strong pipeline of new product development, the company continues to grow in each of their key areas
What you will be doing:
- Managing the pharmacovigilance team.
- Managing the pharmacovigilance systems in line with legal requirements.
- Identifying and implementing practices for improvement.
- Overseeing external PV Providers.
- Reviewing and updating SOPs as required.
- Collating all relevant suspected adverse reactions reported to the company and affiliates.
- Managing the maintenance of the PV system SOP’s and the associated PSMF
- Overseeing completion of review of worldwide scientific literature on a weekly basis.
- Ensuring relevant and timely reporting to competent authorities.
- Making sure all PSUR and medical variation applications are planned, tracked and obtained in a timely manner.
- Tracking compliance of quality, completeness and timeliness for ICSR/PSUR reporting requirements and partner safety data exchanges.
- Coordinating and ensuring the allocation of post marketing review meeting responsibility, and provide input and oversite on an ongoing basis.
- Facilitating third party and accreditation body audits; including contractors and PV service providers
- Maintaining a program for audit pharmacovigilance system and service providers.
- Collaborating with regulatory to ensure label updates arising from pharmacovigilance activities are implemented.
- Ensuring EU/UK regulatory compliance as applicable.
- Fulfil the legal requirements of the Qualified Person role as defined in EU and UK legislation
- Ensuring QPPV has authority to recommend changes in pharmacovigilance procedures to meet EU and UK requirements.
- Development and oversight of the post Brexit UK PV system and how it links to the global PV system.
- Ensuring all key checks required by the QPPV are identified and completed in a timely manner.
- Making sure that requests from the Competent Authority are tracked and answered appropriately.
- Responsible for answering Medicines Information and Product Information queries and handling Adverse Drug Reaction reports.
- Ensuring that PASS reports are properly assessed in terms of safety content and conclusion in the report
- Implementing clinical safety processes to support any new clinical studies if applicable.
- Reviewing and updating PV agreements for all contractual arrangements
- Ensuring reconciliations are carried out as outlined in the agreement.
- Managing the development of risk management plans and risk minimisation activities.
- Overseeing the maintenance and update of the PSMF, review and approve same.
- Answering and addressing of referrals from the PRAC as applicable
- Acting as central point of contact to the competent authorities on a 24-hour basis as the QPPV.
- Acting as the contact for the out of hours emergency medical information phone line.
- Implementing electronic reporting of ICSRs.
- Populating the XeVMP using EudraVigilance and participating in completion as required and review.
- Streamlining the global safety systems to ensure seamless communication with partners throughout Europe.
- Collaborating with marketing to ensure consistent collection and reporting of adverse event data to worldwide regulatory authorities.
- Tracking and highlighting updates to EMA and local drug legislation as it applies to EU and UK regulatory Pharmacovigilance requirements for investigational and post-marketing drug/biologic products.
- Ensuring compliance with pertinent GVP, GCP, GMP, ICH, international, and local regulations as well as adherence to SOP work instructions and guidance documents as they pertain to Pharmacovigilance practices in commercial marketing and clinical trials.
- Optimising the use of resources at all times.
- Ensuring training for stakeholders with respect to safety systems and European pharmacovigilance practices.
What you need to apply:
- Bachelor’s degree in pharmacy, biology, nursing, toxicology, medicine or an equivalent degree from the Life Science field
- Experience in pharmacovigilance/drug safety/medical Information within a commercial pharmaceutical environment
- Expert knowledge in EU and UK PV legislation
- Experience in regulatory agency inspection planning, preparation, conduct, management and agency interactions
- Experience working in a multidisciplinary team