Associate Director/ Director - Pharmacovigilance Services

About The Role:

Director, Pharmacovigilance Services is responsible to lead the pharmacovigilance function, line managing the senior staff and ensuring required targets in quality, finance, and productivity, including realization, profitability and utilization are being met. Will cross-collaborate with colleagues from operations, finance, information technology and business development to ensure business continuity, liaise with external contractors, as needed, and will be responsible for ensuring audit/ inspection readiness. This leadership position also includes overall pharmacovigilance business development and representing Novotech and building Novotech reputation across clients and partners, both internationally and on domestic projects.

Education Qualification:

. Registered nurse/ pharmacist or with health/ biomedical degree or other related scientific degree/ qualification is required.

. Postgraduate qualifications or certification in clinical trials will be an advantage. Experience, Knowledge and skills:

. Demonstrated ability to lead, mentor and influence others to create a positive working environment for the team.

. Expertise in implementation of Asia Pacific/ Global pharmacovigilance requirements and experience in global safety regulations (ICH GCP, E2B R3) pertaining to clinical trials/ post marketing surveillance.

. Familiarity with a variety of pharmacovigilance Safety databases, Microsoft Office applications, MedDRA and WHO-DD coding.

. Sound knowledge and experience in pharmacovigilance clinical trial/ post marketing surveillance projects.

. Strong verbal, written, and interpersonal communication skills.

. Ability to manage multiple and varied tasks with enthusiasm and priorities workload with attention to detail ability to work in a fast-paced environment.

. Effective Finance understanding to plan, implement, and evaluate project pharmacovigilance budgets and contracts.

Responsibilities:

. Manage staff in accordance with organization's policies and applicable regulations, including without limitation: planning, assigning, and directing work managing performance and guiding professional development rewarding and disciplining employees addressing employee relations issues and resolving problems acting as a coach and mentor for subordinates as they develop in their role.

. Participate in the selection and onboarding process for new staff by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs.

. Ensure that staff have the proper materials, systems access, and adequate training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable.

. Ensure line reports compliance with Novotech SOPs, ICH GCP Guidelines and regulatory requirements and they understand the company policies and procedures appropriate to their position.

. Identify and assign qualified staff for project team based on the project requirements and the development of the project team.

. Manage and review the workload and quality of line reports work performance supports the creation of appropriate corrective action plans to prevent or correct deficiencies in performance of staff.

. Any other responsibilities as assigned by the line manager.

. Evaluate current processes, assess alignment of safety implementation and compliance with regulatory expectations, guidelines, and mandates.

. Ensure inspection/ audit readiness for PV team.

. Appraise proposals and budgets, pricing tool and financials for continual success of PV business.

. Ensure PV projects are being managed in line with budgets, scope and agreed timelines to achieve client satisfaction.

. Ensure pharmacovigilance services are meeting the Global standards of ICH GCP and other regulatory requirements.

. Identify and implement learning and development requirements for world class performance across the company. Work with HR & L&D to ensure training needs are met for all pharmacovigilance personnel.

. Work with business development to ensure appropriate support is provided for generating new business.

. Provide pharmacovigilance functional input to management on matters of policy and general operational issues and company growth.

. Ensure all documentation of pharmacovigilance methods and policies is up to date and compliant with client requirements, current regulations, and guidelines.

. Manage resource planning, assigning, and directing work including staff hiring and terminations.

. Conduct regular performance review of line reports.

. Considerable technical and/or management responsibilities, be accountable for the service delivery of the team.

. Responsible for the finances budget/performance of the team(s)/ Dept.

. Provide support for marketing activities as required.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.