PV COMPLIANCE MANAGER - United Kingdom
Company: PRA Health Sciences
Location: United Kingdom
Closing Date: 11 Feb 17
Type: Full Time
Salary (£): Competitive
Benefits: Excellent Salary and Benefits
An outstanding opportunity to join one of the world’s leading contract research organisations and be part of a dynamic and growing international company. Join PRA Health Sciences as a PV Compliance Manager and help realize your career potential.
PV COMPLIANCE MANAGER
Location: United Kingdom
As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.
At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.
At PRA, borders do not create boundaries. PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.
For more information please see our website: www.prahs.com
Compliance and Training Manager is responsible for managing compliance and training activities in support of the strategic vision and initiatives of the global PV Compliance and Training. Principal responsibilities include but are not limited to:
- Manage projects and perform accountabilities for the following primary functions:
- Compliance/ Audit/ Inspection related activity
- Non GxP Guidance
- PV Training
- Responsible for regulatory intelligence processes impacting global Pharmacovigilance.
- Perform root cause analysis and implementation of process improvement strategy to ensure alignment with business objectives.
- Prepare data, interpret and perform impact analysis regarding metrics for case processing and regulatory expedited reporting to regulatory authorities and LOCs
- Manage the investigation of non-compliance and implementation of corrective measures where required
- Develop and distribute regular reports regarding global compliance activities to key stakeholders
- Author and review quality documents and compliance and training processes
- Perform impact analysis for PV compliance strategies and working practices, including input into safety exchange agreements, CRO oversight, SOPs, and other pertinent PV processes
- Support global efforts to ensure PV regulatory inspection or internal audit readiness for dedicated PV or GCP inspections/audit
- Address audit/inspection findings as needed
- Manage corrective and preventative action plans (CAPAs) including assessment of root cause and establishment of timeframes
- Serve as departmental trainer and provide training in all relevant areas, excluding the safety database
- Review compliance and training procedures for local and regional offices in support of global alignment activities
- Regulatory intelligence: Review relevant PV regulations in regions to identify updates needed to PV compliance and training processes
- Responsible for management of PV training schedule
- Serve as the contact point for PV training needs
- Liaise with QA Documentation and Training Department as required
Pharmacovigilance System Master File (PSMF) Not all Compliance and Training managers will be involved in PSMF activities
- Co-ordinate maintenance and updates to the PSMF in line with GVP II and any other relevant GVP modules, to ensure inspection readiness of the document
- Liaise closely with the EU QPPV/deputy and cross-functional areas
- Contribute towards drafting/reviewing the procedural documentation relation to the PSMF, and continuously finding improvements to streamline the process
- Act as the main point of contact regarding requests for sections of the PSMF for other activities, e.g. due diligence requests
- BS, RPH, RN HCP, or Life Science required; Post-graduate degree or equivalent preferred
- In depth knowledge and comprehension of Pharmacovigilance regulations, compliance practices and ability to interpret multiple requirements into concise clear instructions. Familiarity with inspections and audit procedures
- Works strategically to realise organizational goals
- Critical thinking and decision-making skills
- Exercise independent judgment
- Understanding Takeda business needs with global business perspective and professional attitude
- Excellent level of computer literacy with Microsoft applications
- Excellent organization skills and ability to prioritize
- Demonstrate integrity
- Relate well to people at all levels
- Motivate and empower others
- Work productively in a high pressure environment
- Ability to identify proactively and anticipate risk of non-compliance in a complex environment
- Knowledge of compliance international Regulations and ICH environment foundations
- Good analytical/judgment capabilities to understand/analyze/synthesize and communicate
- Project Management abilities
- Strong knowledge of business area and interactions with strong regulatory environment and ability to identify and understand proactively the interactions necessary for achieving business goals and objectives
- Able to manage both time and priority constraints and to manage multiple priorities simultaneously
- Attention to details, computer literacy, knowledge of safety database
- Take initiative and autonomous action
- Able to lead teleconferences and meetings
- Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / caching skills
Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment. As we continue to expand, there will be career opportunities on a truly global scale.
If you have any questions please email email@example.com or call our recruitment department at +44 (0) 1189 5185 63.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.