Abbott
REGIONAL PHARMACOVIGILANCE MANAGER Medical, Pharmacy or Life Sciences degree
PRIMARY
JOB FUNCTION: Oversight of the performance of Abbott Affiliate
pharmacovigilance functions in the given region/territory to ensure they are in
line with company standards and local legislative requirements.
Administrative
supervisor of GPV Satellite organization based in India.
Liaising
with other regional I&D functions.
Assume
leadership for Medical Safety topics in the designated region/territory.
Compliance:
Awareness of PV compliance and performance at the Affiliate level. Escalation
of issues according to the applicable procedures.
Audits
and Inspections: Appropriate support for CAPA activities and oversight of
completion of activities
Training:
Develop training matrix for Regional PV and local PV Staff (ASRs and back-ups).
Organize Global PV Meetings to include technical PV training, GPV initiative
updates, best practice sharing and to give ASRs opportunity to meet other ASRs
and share experiences and issues.
PV
Quality System: Support implementation of global SOPs at local level. Author
global SOPs related to training (for local PV staff) and local PV system.
Advice
and guidance: Provide ad hoc advice and support to ASRs on operational PV
issues and liaise with GPV for resolution.
ASR
Development: Provide feedback on
potential ASR talent which may be redeployed in other regional/global PV roles
Local
PVAs: Work with PV Contracts to maintain consistency in local SDEAs
Regulatory
Intelligence: Understand local regulations and guidelines and assess potential
impact on global process and procedures. Notify GPV and QPPV of potential impact
and assist in determination of appropriate local or global strategy to
accommodate requirements
Interfaces:
Work in collaboration with the applicable stakeholders (e.g. Global Regulatory
Affairs, Global Medical Affairs, Global Clinical Development, QA PV) in order
to maintain a timely and complete exchange of information relevant to PV and
optimize the support for the local PV staff.
Medical
safety: support and guide ASRs regarding safety surveillance (incl. safety
signaling, preparation of local annexes to globally prepared RMPs and local
RMPs, PSUR planning and preparation, HHAs. Additionally, support and guidance
for clinical studies and drug development, participation DRBs and in due
diligence activities for regional L&A options.
Process
improvement: Provide local area perspective on processes to GPV to enhance
productivity and efficiency
Other:
Sponsor/lead/contribute to certain local and global projects.
POSITION
ACCOUNTABILITY/SCOPE:
Application
and maintenance of consistent standards for PV across all Affiliates
Adherence
to global and local SOPs
Appropriate
and adequate training for ASRs
Timely
identification and appropriate response to areas of non-compliance
Audit
and inspection readiness in Affiliates at all times
Real-time
response to ASR questions
Administrative
oversight of the GPV staff located in Mumbai, India.
EDUCATION:
Ideally
licensed physician or graduate with a Medical, Pharmacy or Life Sciences
degree.
Computer
literacy (Windows, MS Office).
Fluency
in English language.
EXPERIENCE/QUALIFICATION:
At
least three years of experience in the pharmaceutical industry in
Pharmacovigilance, Medical Affairs or Clinical development
Knowledge
of Pharmaceutical Regulations in Asia, especially for pharmacovigilance
Attention
to details, flexibility, commitment to quality
Availability
for travel (30-50%)
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