Post: Associate Manager, Pharmacovigilance-1409928
PURPOSE
Supervise Pharmacovigilance (PhV) staff responsible for adverse event/ICSR processing and PhV systems to include project resource assignments, staff hiring and staff terminations. Responsible for staff training and professional development. Assist in assuring corporate and departmental quality, financial and productivity targets are achieved.
Supervise Pharmacovigilance (PhV) staff responsible for adverse event/ICSR processing and PhV systems to include project resource assignments, staff hiring and staff terminations. Responsible for staff training and professional development. Assist in assuring corporate and departmental quality, financial and productivity targets are achieved.
RESPONSIBILITIES
· 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.
· 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.
· 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.
Mentoring Contract management and Interviewing:
Definition: Enhancement of the formal training program, through the provision of on going, on-the-job guidance & support.
Activities include:
· Provision or on-the-job training & support to other safety associates.
· Regular meeting with safety associates team across the floor.
· Completion or mentoring checklist.
· Assist with credentialing.
· Day to Day management of 3rd party contractors e.g: overseeing holiday requests, credentialing process, liaison with agencies, act as a key contact person for contract concerns and issues.
· Recruitment agency liaison
· Contribution with the interview and final selection process
· New starter administration process
Definition: Enhancement of the formal training program, through the provision of on going, on-the-job guidance & support.
Activities include:
· Provision or on-the-job training & support to other safety associates.
· Regular meeting with safety associates team across the floor.
· Completion or mentoring checklist.
· Assist with credentialing.
· Day to Day management of 3rd party contractors e.g: overseeing holiday requests, credentialing process, liaison with agencies, act as a key contact person for contract concerns and issues.
· Recruitment agency liaison
· Contribution with the interview and final selection process
· New starter administration process
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
· 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
· 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
Qualifications
Individuals with a Pharma degree (4-yr degree), a Master's in Pharma Sciences (MPharm-6 yr degree), or a Masters in Life Sciences (5 yr degree), Nurse or graduate with 4-year degree in Life Sciences or health/biomedical degree with 4years of relevant clinical experience including 1-2 years experience managing clinical projects/ Pharmacovigilance operations or equivalent combination of education, training and experience.
Additional Information:Individuals with a Pharma degree (4-yr degree), a Master's in Pharma Sciences (MPharm-6 yr degree), or a Masters in Life Sciences (5 yr degree), Nurse or graduate with 4-year degree in Life Sciences or health/biomedical degree with 4years of relevant clinical experience including 1-2 years experience managing clinical projects/ Pharmacovigilance operations or equivalent combination of education, training and experience.
Experience: 4-6 years
Location: Bangalore
Education: B.Pharm, M.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Job Id: 1409928
End Date: 26th July, 2014
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