Proclinical is advertising an exciting opportunity for an Associate Director/Director, Clinical Pharmacovigilance Operations position with a leading biopharmaceutical company. This patient-focused company, which boasts a growing pipeline of investigational drugs, is seeking for an Associate Director to come on board their London based team.
The Associate Director/Director, Clinical Pharmacovigilance Operations will be responsible for overseeing and managing PV Operations staff, including clinical trial quality standards, adequacy of training, job performance, and career development.
Job Responsibilities:
- Defining PV project team strategy and managing or leading functional and cross-functional projects as a key representative of PV Operations management team.
- Overseeing PV Operations team activities with clinical trials management, clinical trial convention, and/or clinical trial submissions activities.
- Ensuring study management team leads in compliance with all clinical trial reporting requirements to partners and regulators.
- Establishing and/or identifying best practices for continuous improvement of case quality, compliance, and process improvements.
- Utilising strong operational management skills to ensure the team is achieving the strategic business goals of PV.
- Serving as a resource to the leadership team on the operational strategy, both short and long term, for the PV Operations function.
- Demonstrating the ability to handle increasing responsibilities, as scope of responsibilities may change (team growth, or integration efforts across other department organisations).
- Effectively representing PV on multidisciplinary teams; an ability to evaluate and analyse procedural gaps.
- Partnering with Clinical Operation Study leads to ensure the alignment of process handoffs between the clinical and PV teams, including the oversight of PV work performed by Clinical CROs.
- Serving as a consultant to PV management in an area of clinical trial conventions and expertise and acting as a spokesperson for the PV organisation in matters pertaining to its policies, plans, and long-term strategic trial objective.
- Gathering information of assigned tasks or activities for one or more projects.
- Identifying and pursuing global and long-term goals for the PV Operations team, in collaboration with department head, considering and providing support for overall strategic goals for the dept.
- Shaping key department goals and objectives, driving process and operational efficiencies, and contributing to ongoing development of innovative best practices, both internally and with other cross-functional groups.
- Contributing to the development of standardised clinical trial practices, procedures, metrics, and measuring productivity and performance of PV operations.
- Working independently, establishing work priorities, and direction with minimal input.
- Collaborating with all PV functional groups to ensure compliance with regulations and PV standards to ensure that PV is complaint with all current regulations pertaining to clinical trial product safety as well as company policies.
- Providing advice and support to other functional groups with respect to drug safety standards and requirements pertaining to clinical trials.
- Providing support and back-up for Associate Director/Director or Group Head.
Skills and Requirements:
- A degree in biological sciences, nursing, pharmacy, or medicine preferred.
- A minimum of 8 years of relevant drug safety, drug development, or clinical trial experience.
- A minimum of 5 years previous management experience.
- An in-depth knowledge and thorough understanding of FDA, EU and global regulations, ICH guidelines, and GCPs that govern drug safety and pharmacovigilance.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kevin Hansberry on +44 207 440 0636 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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