Director - Drug Safety
The position directly reports to the Vice President of Global Drug Safety.
This role covers both our Consulting services and transactional delivery of services to clients and requires a strong understanding of strategic and operational consultancy with clients holding multiple products across a range of locations and jurisdictions.
The main purpose of this role is to support the operation of the Drug Safety department in the company by providing oversight and coordination of assigned activities and projects in the department.
As part of a lead role, you will also be responsible for supporting the development of PV and other departments from time to time, to ensure Arriello’s growth meets the needs of our employees and clients.
What will be your key responsibilities:
- Act as the technical lead for Drug Safety services and safety activities in the company and support the strategic growth for the function in line with agreed goals to achieve revenue
- Provide high level strategic support to clients for the services we provide, and ensure we capitalise on relationships with clients to support their needs
- Actively engage in Thought Leadership and support the development of these programs, including conference and publication interviews and, conference presentations together with the marketing team
- Support the strategic growth of our business in the identification of key hiring needs (locations and levels) to meet client expectations and Arriello’s business goals as agreed with the Board
- Mentor and coach the team where needed to ensure we continue to grow professionally and sustainably
- Support managers in meeting; resources, capacity, and allocation plans in line with business standards and goals
- Support managers with development of training plans in line with training budget and to ensure we grow our key employees
- Support managers on project and technical issues or client complaints where needed
- Escalate to Senior Director, Drug Safety any issues that may influence the operation of the Safety department and/or any other compliance and quality issues related to day to day operations and impact on clients
- Identify improvements in and support Director, Drug Safety in operations and processes, technology, facilitate process change management and remedial actions
- Participate in internal and external audits and authority inspections as and when needed
- Supports Director, Drug Safety in the delegation of projects in line with company procedures to support client’s expectations
- Participate in internal and external trainings as and when needed
- Participate in company marketing and promotional activities, as required
- Participate in company business development activities, as required
- Finds new business opportunities for current or future clients
- Work cross-functionally and in collaboration with key stakeholders/customers both internal (e.g., Commercial, Project Management, Quality management, Regulatory, etc.) and external (e.g., Competent Authorities, Clients, Vendors, etc.)
- Effectively build working relationships based on transparency, trust and clear communication
- Promote and act as a role model for cross-functional teamwork and collaboration
- Actively participates in proposal reviews, bid defences, pre-qualification audits, kick-off meetings, and other project-initiation meetings as and if required
- Supports the maintenance of team tools including but not limited to project trackers, capacity planners, and monthly summaries of activities conducted by the primary unit
- Supports the review and optimisation of the department utilisation and ensuring agreed targets are achieved
Details.
Location: abroad
Employment: full-time
Education: postgraduate studies
Language: English
For graduates: no
Salary: by agreement
Benefits:
- Hybrid or remote working (Use of our offices in various locations, co-sharing workspace or home office options)
- 5 weeks holiday plus national holidays in your given location
- 3 personal days
- Flexible benefits, based on location
- Home office stipend
- Annual bonus program
- Other employee Bonuses (spot bonuses and employee nominated bonuses)
- Dog friendly offices
What experience should you have:
- Graduate in pharmaceutical sciences or related fields – medicine, pharmacy, life sciences – advanced degree preferable
- Proven experience working in a Pharmacovigilance function or consulting business, with experience across product lifecycle and exposure to global safety operations. Current/previous positions must include experience at a service provider/CRO, where you held the appropriate seniority expected for this role.
- Previous experience working in a leadership and people management position required, ideally working with large teams across multiple locations
- Previous experience acting as EU QPPV or Auditing is preferable
- Detailed knowledge of Safety processes, directives, regulations and guidelines (ICH, GVP, GCP, CIOMS, etc.)
- Minimum of 15 years of experience working in a medical or safety departments with demonstrable expert knowledge of medical terminology
- Experience working with variety of safety databases
- Participate at industry events and speak/present on interesting topics
- Previous experience working at a healthcare agency (MHRA, EMA, FDA, etc) is a plus
- Fluent verbal and written English. Any other languages are a plus.
- Ability to delegate and oversee work within the department
- Organizational and time-management skills, able to prioritize work and adhere to deadlines
- Ability to provide training and guidance to other department members
- Excellent team player, able to build an effective team
- Excellent communication and consulting skills
- Maintains a positive, result oriented work environment
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