Quintiles is the world’s leading provider of biopharmaceutical services. With a network of more than 27,000 professionals working in more than 80 countries, we have helped develop or commercialize all of the top 50 best selling drugs on the market. With extensive therapeutic, scientific and analytics expertise, we help biopharmaceutical and health sciences customers navigate the increasingly complex landscape with more predictability to enable better outcomes.
Job Title : Associate Manager, Pharmacovigilance
Job Description :
- Supervise PhV staff in accordance with organization's policies and applicable regulations. Responsibilities include
- planning, assigning, and directing work; performance appraisal and professional development guidance; rewarding and
- disciplining employees; addressing employee relations issues and resolving problems.
- Approve actions on human resources matters.
- Monitor and motivate staff to achieve and maintain acceptable levels of performance.
- Work closely with other managers to address problem areas, staffing needs, equipment needs, and projected peak workloads.
- Identify training and development needs of staff.
- Lead and encourage direct reports in continuous improvement of department work processes, procedures and infrastructure.
- Monitor and ensure that project processes and department deliverables meet expected quality, financial and productivity targets.
- Assist with meeting department realization targets
- Assist and co-ordinate across other teams in Global PhV with specific project processes requests.
- Monitor, assess and report utilization of staff. Identify and implement solutions for poor utilization of staff.
- Ensure department metrics are collected and meet expected tar gets.
- Assure timely movement of project work through the process steps, in accordance with governing SOPs, ICH/FDA
- regulations and guidelines, working instructions and client expectations.
- Implement and support operational decisions as determined and instructed by senior management.
- Assist management with departmental resource planning and work scheduling for current and projected projects to ensure deliverables are met.
- Remain current with new software/hardware product releases in an effort to streamline and compliment existing
- processes through use of software/hardware.
- Ensure that staff have been trained on and are following required Standard Operating Procedures (SOPs), Good Clinical
- Practices (GCPs), FDA and ICH guidelines and regulations, Working Instructions and project instructions.
- Develop and implement plans for measuring and improving employee engagement.
- Depth knowledge of AE and spontaneous event processing
- In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical
- Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- In-depth knowledge of departmental SOPs
- Skill in use of multiple safety databases
- Extensive knowledge of Pharmacovigilance and safety surveillance
- Effective staff management skills
- Strong project management and communication skills
- Excellent motivational, influencing and coaching skills
- Ability to work on multiple projects and manage competing priorities
- Effective leadership skills
- Strong presentation and report writing skills
- Strong customer focus skills
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
Skills :
Eligiblity : B.sc / M.sc Life science
Experience Required : 1-2 years
Location : Bangalore
To apply, fill the form in the mentioned website: http://www.biotecnika.org/content/july-2014/shape-you-career-pharmacovigilance-domain-quintiles-apply-now?page=0,2
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