Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, iversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company now employs approximately 70,000 people and markets its products in 130 countries worldwide.
Post: Manager Regional Pharmacovigilance - Asia
Job Description:
• The Manager Regional PV is responsible for a number of specific countries as determined by the Associate Director Regional Pharmacovigilance. The purpose of the role is to have oversight of the performance of Abbott Affiliate pharmacovigilance functions in a given region to ensure they are in line with company standards and local legislative requirements.
1. Compliance
Local compliance monitoring is the responsibility of the Affiliate. The Manager Regional PV must be aware of performance of Affiliates in their countries of responsibility and work with ASRs to ensure:
• Timely investigation and review of any non-compliance issues
• Appropriate CAPA activities and completion of activities
• Compliance trending within and across regions
• Escalation of issues to GPV and QPPV via the Director Regional Pharmacovigilance
• Compliance with worldwide regulations
2. Audits and Inspections
• Provide input to risk-based audit schedule
• Provide support to regional Affiliates for audit and inspection preparation using a risk based approach
• Assist Affiliate with development of audit corrective action plan or provide input to inspection response as appropriate
• Monitors completion of CAPAs
• Flags issues for GPV and QPPV via the Associate Director Regional Pharmacovigilance
• Share common audit findings with Affiliates (working closely with QA)
3. Training
• Responsible for ensuring new ASRs are appropriately trained utilising most appropriate medium and format for a given region.
Assist in development and maintenance of a repository of approved training materials. Establish mandatory training elements for all new ASRs and back-ups.
• Ad hoc training to be delivered.
• Attendance of mandatory training to be monitored, tracked and documented.
• Annual training meetings to include technical training, GPV initiative updates, best practice sharing and to give ASRs opportunity to meet other ASRs and share experiences and issues.
• Provide input to ASR training matrix
4. SOPs
Support implementation of global SOPs at local level. Where global SOP requires action at local level must monitor/track timely completion.
• Activities should take into account local legislative requirements.
• Make recommendations for any enhancements to global SOPs in relation to affiliate activities.
• Share regional best practices for SOP content and implementation
5. Advice and guidance
Provide ad hoc advice and support to ASRs on operational PV issues and liaise with GPV for resolution.
6. Local SDEAs
• Provide support and advice to Affiliate on development of local SDEAs and reviews before submission to GPV for final review.
• Work with PV Licensing to maintain consistency in local SDEAs
• Provide assistance to Affiliate with local compliance to SDEAs
7. Regulations and guidelines
• Understand local regulations and guidelines and assess potential impact on global process and procedures.
• Notify GPV of potential impact and assist in determination of appropriate local or global strategy to accommodate requirements
• Be aware of any new legislation or guidelines in designated region.
8. ASR Development
• Provide feedback on potential ASR talent which may be redeployed in other regional/global PV roles
• Work in collaboration with IMD to assist in ASR development e.g. involvement in GPV initiatives/projects
9. Process Improvement
• Provide local area perspective on processes to GPV to enhance productivity and efficiency
10. Other
• Sponsor/lead/contribute to certain local and global projects
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Candidate Profile:
Minimum Education:
• Ideally licensed physician or graduate with a Life Sciences or Pharmacy degree.
• Computer literacy (Windows, MS Office).
• Fluency in English language.
Minimum Experience/Training Required:
• At least three years experience in the pharmaceutical industry in Pharmacovigilance
• Knowledge of Pharmacovigilance Regulations in more than one country
• The ability to give attention to detail
• A track record of commitment to quality is essential.
• Flexible and pro-active
• Availability for travel (30-50%)
Additional Information:
Exp: 3 yrs
Location: Mumbai
Education: B.Sc; B.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR, Pharmacovigilance
Keyword or Job ID: 117413BR
End Date: 27th Aug, 2012
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