Location

Hartley Wintney, Hampshire

Job Type

Hybrid (3 days in office) Full-time

Position

  1. The PV Manager has overall responsibility for the conduct and delivery of their client’s PV activities and deliverables within TMC PV, as well as input to the development and maintenance of TMC PV’s key
  2. The post-holder is responsible for providing support and input to PV advice given to clients and colleagues on challenging, multi-geography projects; and helping to translate client requirements into tangible actions.
  3. Involved within TMC at an operational level, the PV Manager will also be responsible for the timely delivery of assigned PV projects and individual case management with regards to quality and compliance, adhering to company standards for pharmacovigilance, both in clinical trials and with marketed products.
  4. The post-holder will also support the preparation and maintenance of essential PV documents such as RMPs and the PSMF, as well as PV activities including benefit-risk monitoring and signal detection.

Specific duties and responsibilities of the role

The PV Manager is required to:

1.1 Line & People Management

  • Line management, as delegated by the Head of PV; holding regular line management meetings, one-to-ones, annual appraisals and encouraging/directing their progression and performance within the company.
  • Supporting the identification of skills gaps, both training and competency, at an individual, departmental and Company level; making appropriate recommendations to remedy current and future training deficits.
  • Supporting the workforce planning activities to allow for current and pipeline projects to be appropriately resourced; identifying hiring requirements (for both internal and Associate positions) and to recruit for approved vacancies.
  • Establish, develop and maintain effective working relationships with Associates, including on- going performance evaluation to ensure high quality outputs.

1.2 BD, Budget and Proposals

  • Attending conferences and exhibitions where required.
  • Support the wider team in the preparation of project proposals and associated budgets, as required.
  • Manage their project budgets and timelines, including responsible for managing change orders with clients, where appropriate.

1.3 Project Management

  • Under the guidance of the Head of PV, assume overall responsibility for the delivery of TMC PV projects to ensure consistent delivery of high-quality deliverables on time, to budget, while fulfilling client needs and maintaining engaged project teams, specifically;
  • Take responsibility for planning, scheduling and coordinating the technical and management aspects of projects; leading client/contractor meetings when necessary.
  • Delegate project tasks to designated project teams; this may include project co-ordination, logistics and travelling and document control activities.
    Report project financials and project status to the relevant person/department at agreed intervals.
  • Attending off-site client meetings, if required.
  • Recognise and manage significant scope creep within projects.

1.4 Pharmacovigilance General Tasks

  • Working in the PV Department alongside Physicians and PV specialists, as well as interacting with PV Associates, the role is primarily one of responsibility for the timely delivery of PV projects with regards to quality and compliance, adhering to company standards for pharmacovigilance, both in clinical trials and with marketed products.
  • The role encompasses liaison with other PV professionals who work with TMC as well as supporting the maintenance of the PV System Master File. The post-holder will support the management and improvement of single case processing and the preparation of periodic reports.
  • Subject to experience and technical competence, the post-holder will input to the preparation and maintenance of strategic PV documents such as RMPs and the PSMF, as well as PV activities including benefit-risk monitoring and signal detection.

1.5 Specific task of the PV Manager include:

  • Builds and maintains good relationships across all TMC functional units.
  • Provide input and support to TMC to ensure compliance with current PV regulatory requirements.
  • Liaison with the Head of PV, EEA QPPV / Deputy on PV activities as required.
  • Management of SAEs & ICSRs.
  • Liaises with the Sponsor / MA Holder on expediting Adverse Event reports as required.
  • Management of Periodic Safety Update Reports (e.g. DSUR, PADERs, PBRER & PSUR).
  • Participates in TMC project team meetings as required.
  • Supporting the EEA QPPV PV team with regional expertise in the Americas, where applicable.
  • Management of essential PV documents (e.g. REMS, RMPs, SMPs, PSMF etc.).
  • Supporting the conduct or supervision of PV audits of suppliers, clients, or any part of the TMC PV system.
  • Supporting of PV Quality Management System. Supporting the management of PV Inspections.
  • Maintains the safety section of the Trial Master File (TMF) as required.
  • Supporting the maintenance of the TMC PV System Master File (PSMF) as delegated by the EEA QPPV / designee, where applicable.
  • Database administration support, including database build, validation, running listings, implementation of upgrades, as required.
  • Supporting case processing activities, including but not limited to: triage, data entry, quality checks and submissions to regulatory authorities.
  • Support US and Latin America PV activities, including: REMS development/maintenance, regulatory authority PV expedited submissions/ periodic reporting.

All employees are required to:

  • Familiarise themselves with the Company Policies and Procedures, held on the Shared Drive. Act at all times within the Company Rules, Policies, Procedures, and any other statutory requirements.
  • Behave professionally and be personally well-presented at all times (including remote interactions); both with colleagues and clients.
  • Be proactive, bring ideas, suggestions and contribute to business improvement (including business development).
  • Undertake training as required.
  • Attend staff and team meetings as required.
  • Observe health and safety procedures in the workplace to ensure personal safety and to safeguard the interests and safety of colleagues, customers and visitors.
  • Support and promoting the principles, processes and quality culture within TMC.
  • Undertake other duties and responsibilities as appropriate since all staff are expected to work flexibly within their skill level to respond to changing priorities and make sure that customer needs and business objectives are met.

Person specification

  • Exceptional interpersonal skills
  • First-class administrative and organisational skills
  • Self-motivated person
  • Disciplined to work remotely
  • Proactive approach to work, demonstrating initiative and reliability. High standard of written and spoken English, with a keen eye for detail
  • Outstanding work ethic and commitment to meeting timelines without compromising quality

Education level and Qualifications

Essential

  • Relevant degree in a Life Science discipline or equivalent, or a recognized nursing qualification

Essential

  • Specific post-graduate qualification in Pharmacovigilance
  • Additional language

Specific Knowledge, Experience and Technical Skills

Essential

  • Expertise in Pharmacovigilance in the Pharmaceutical Industry including working within regional and global regulatory frameworks.
  • Working knowledge of GVP and relevant global legislation.
  • Familiarity with MHRA, EudraVigilance, Health Canada, FDA FAERS, and LATAM PV databases.
  • Understanding of case handling/processing/submission for both clinical trials and marketed products
  • Experience of periodic report preparation and review

Desirable

  • Experience within the Service Provider (CRO) environment
  • Experience of signal detection & management; safety risk management; and knowledge of the requirements for the PV System Master File
  • Experience supporting post-marketing safety commitments such as FDA-mandated post-marketing studies (PMRs/PMCs).
  • Capability to work fully remote and to build remote teams