GlaxoSmith Hiring Associate Manager Literature Evaluation Bachelor’s Degree - Life sciences (Biology, chemistry, Pharmacy, medicine Apply Now
Job Purpose and Key Responsibilities:
Manage a group of scientists who conduct PV SERM literature
activities by:
appropriate management so that the team consistently, efficiently
and reliably performs activities supporting GSK’s regulatory obligations
related to PV SERM literature review for purposes of of aggregate report
inclusion and potential safety signal identification
providing management oversight to maintain and drive quality
across the team
ensuring that the respective team is staffed by appropriately
skilled and trained individuals so that the team can successfully meet the
required performance standards
developing and sharing pharmacovigilance knowledge and
experience with team members, with proven ability to support and coach direct
reports
readiness, experience and ability to work globally both in
the internal and external to GSK environment, interacting with all different
levels of stakeholders
Key responsibilities
Supervise and support the work of a team of direct reports
performing PV SERM literature surveillance activities according to appropriate
regulations and agreed processes, including performing management monitoring of
all activities carried out by the team.
Ensure timely production of key deliverables by team,
including but not limited to:
Screening and reviewing literature search results
(articles/abstracts/citations) for purposes of aggregate report inclusion and
potential safety signal identification
Maintaining and documenting up-to-date product knowledge to
aid in literature review
Balance resource requirements and promote a pragmatic,
flexible, focused approach to workload
Ensure that direct reports have business objectives set,
development plans in place and complete all trainings, as required
Develop and share pharmacovigilance and literature review
knowledge and experience with team members
Ensure that discussions needed for, and priority of safety
related findings/ signal reviews with the SERM product specialists / SERM
physician, communications, escalations and documentation of the outcome of
signal detection process are done efficiently.
Collect data on time, cost, quality and compliance and
ensures team meets targets for all measures including defined Key Performance
Indicators (KPIs)
Aid direct reports with decision-making, problem solving and
work prioritization; provide management review and quality check support as
required.
Demonstrate expertise in quality checks for review of
literature search results (articles/abstracts/citations) for purposes of
aggregate report inclusion and potential safety signal identification evaluated
by team members.
Identify or participate in continuous process improvement
activities related to area of responsibility or as requested
Maintain good documentation practice and be the Point of
Contact in case of inspection/audit
Maintain appropriate organizational networks
Competencies:
Minimum level of job-related experience required: 9 to 12
years of relevant industry experience
Pharmaceutical industry experience (e.g. drug safety,
regulatory, clinical development, medical affairs)
Literature review and/or library sciences experience and
knowledge of the principles of causality assessment and the evaluation of
safety signals preferred.
Knowledge of key pharmacovigilance regulations and
methodologies
Good people management skills (5 to 10 people)
Can communicate effectively in local language and English.
Has strong sense of urgency, able to effectively prioritize
such that key issues or emerging high priority matters are handled in a timely
and effective way with appropriate attention to detail.
Service-oriented attitude and ability to interact effectively
with all levels of personnel in an interdisciplinary and matrix environment.
Ability to define and implement new processes and quality
initiatives
Strong interpersonal, presentation and communication skills
Education –
Bachelor’s Degree - Life sciences (Biology, chemistry,
pharmacy, medicine or other relevant scientific discipline)
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