Pharmacovigilance Project ManagerUK or Ireland [Work from Home], United Kingdom
Based in the UK and Ireland our client is pleased to be adding this most pivotal role to their Pharmacovigilance team The PV/Project Manager will provide leadership, management, general over-sight and direction for all PV projects, including but not limited to clinical drug safety and post-marketing pharmacovigilance, clinical endpoint adjudication, and data safety monitoring committee management. The PV Manager will also be responsible to ensure client satisfaction, project team management and communication, quality, adequate resource planning and allocation, and financial performance.
- The PV Manager will be responsible for management, general oversight, and direction for PV projects . Reports to Managing Director or designee
- Directly supervises Junior PV personnel, new starters
- Including clinical endpoint and data monitoring and review, and clinical and post-marketing PV projects
- Responsible for the performance of the PV project team, the PV Manager will be a point of communication contact and liaison with internal and external stakeholders, strategic planning teams and project review teams including Quality, financial performance and customer feedback. The PV Manager will be responsible for consistent and complete communication between all members of the project team including vendors, sub-contractors, clinical operations, regulatory affairs, Medical writing and between the global PV project team and the client. If acting in the Global lead role, the PV Manager will be the single operational point of contact in PV for all communication.
- In activities involving project management, the PM will act as the project manager to ensure that projects run on time, on budget, and in accordance with client contract, Client or company SOPs, quality standards and regulatory guidelines. PMs may also be assigned as SMEs for specific services within IntuVigilance, depending upon their specific skillset and knowledge of that service.
- The PV Manager will serve as the primary point of contact and communication between the company’s PV group, designated Vendors/sub-contractors and the Sponsor/Client/MAH and will be accountable for performance of the entire team assigned on that project
- In addition, the PV Manager will be responsible for providing input, advice and direction for resource planning and allocation working closely with the Global PV Ops. Manager, stakeholders, strategic planning and reviews:
- Management, support, direction, co-ordination and planning for any PV related activities, including oversight of and contribution to PV consulting projects.
- Strategic input, including providing subject matter expertise in the planning and setup of PV projects, including costing, budgeting, resourcing, workflow and process design and analysis.
- Provide training and mentoring to other, less experienced PV Managers/PV Scientists.
- Timely contribution to and strategic input and review of proposals (RFP), and contracts as required.
- Liaison with internal (e.g. business operations, account management) and external stakeholders (e.g. clients, third party vendors, health authorities).
- Represent the company when required, for internal and external matters.
- Provide support in internal and external audits and inspections and work closely with QA to ensure that corrective actions are implemented as appropriate.
- Contribute to PV Operations resource planning and strategy. Contribute to the costing of PV Operations projects, including the review of and improvement of performance metrics and costing tools.
- Attend and lead client meetings and bid-defense meetings.
- Provide timely input and feedback to process improvement.
- Follows ALL ISO Standards with respect to ISO9001, ISO27001, ISO45001, ISO22301 and ISO14001, in particular those related to Information security.
- The PM will be required to maintain PV knowledge and knowledge of ICH GCP and GVP processes as required by regulations and SOPs, and to document competencies appropriately in the training documentation files. PMs will be expected to develop internal and external visibility, e.g. presentations to internal stakeholders, publications in peer reviewed journals and presentations at conferences.
Projects may involve the following tasks:
Clinical trial safety management — receipt, processing, data-basing, follow-up and regulatory reporting of SAEs.
Management of Data Monitoring Committee (DMC) and Clinical Endpoint Committee (CEC): communication with client, team members, DMC and CEC consultants.
Post-marketing PV - receipt, processing, data-basing, follow-up and regulatory reporting of spontaneous adverse drug reactions (ADRs), conduct and review of literature searches, preparation and submission of PSUR/DSURs.
Any other activities as required by lifecycle drug safety and/or post-authorisation services contracted to the company.
Where required, PV Manager will be responsible for the financial management /administration of the function-led projects e.g.
- Maintenance of a project plan
- Monthly revenue recognition and forecast activities
- Invoicing according to contract service and pass-through cost
- Project close out activities
- First point of contact for the client for all financial related issues (e.g. CIS, reminders)
- Coordination/management of project team
- Demonstrable knowledge of drug safety and the drug development processes
- Excellent knowledge of and ability to interpret and apply global safety and other relevant regulations
- Experience in evaluation of safety data and the preparation of safety reports
- Experience with computer applications including database management and pharmacovigilance related computing systems
- Leadership skills — ability to build effective project teams, ability to motivate others, delegation skills, drive and timely/quality decision-making.
- Personal qualities — ability to gain trust and confidence with a variety of clients as well as , good learning ability, managerial courage, action oriented and resilience in a fast paced and rapidly changing environment
- Business/Operational skills — customer focus, commitment to quality management and problem solving
- Influencing skills — negotiation and teamwork
- Effective communication skills — provision of timely and accurate information to stakeholders and strong written and oral communication skills
- Knowledge of business operating procedures (e.g., contract approval, revenues recognition, project close out)
- Working knowledge of the company systems (e.g., ikyzen, Argus SaaS, LMS)
- Basis knowledge of accounting/ excel
- Proficient use of MS Office Suite
- Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification
- Associates/diploma degree in any of the above with appropriate work experience
- Fluent English; Additional languages beneficial
- Minimum 6+ years of drug safety knowledge and experience
- Substantial experience working in drug development and/or healthcare environment
- Project management and/or significant team leadership experience
- Remote work from home
HR Innovate is an equal opportunity Recruiting Agency and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, or disability status. We are committed to protecting your personal data.