As a Safety Pharmacovigilance Staff, you will be responsible for any required administrative support and will be responsible for maintenance of the systems used by the team in terms of ensuring data in the systems is current and accurate
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Signal Detection and Evaluation
Runs routine signal detection process, including review of individual case reports via Case Awareness Tool, literature review, On-Line Signal Management Tool, in partnership with SERM physician, for all products in area of responsibility.
Discusses need for, and priority of safety related findings/ signal reviews with the SERM Team Leader/ SERM physician; communicates, escalates and documents the outcome of signal detection process.
Uses appropriate sources of information and database searches to retrieve relevant data for explorations/ evaluation of signals.
Analyses safety data and discusses the results with the SERM Team Leader/ SERM physician and other key
stakeholders, as appropriate.
Produces accurate and fit for purpose exploratory/ evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data with some level of support from more senior personnel, as necessary.
Routinely monitors safety issues potentially related to a product defect and/or manufacturing issue; communicates with the SERM physician/ SERM Team Leader and/or Manufacturing; documents outcome.
Aggregate Reports and other Regulatory Submissions
Authors periodic regulatory documents (PBRERs) according to the agreed process and timelines, with some level of support from more senior personnel, as necessary.
Supports the Local Operating Companies by preparing license renewal documentation (e.g. Addendum Reports, Line listings, Clinical Overviews) as required for each market.
May author the SERM safety contribution to other global regulatory submissions or answers to safety-related questions from Regulatory Agencies, with strategic guidance from more senior personnel.
Risk Management activities
Authors or assists in the production of global Risk Management Plans/ regional Risk Management Plans for designated products, in consultation with senior colleagues.
May contribute to Regulatory Benefit-Risk Assessments requiring safety team input.
Creates and maintains the Global Product Information (PI) for products supported.
Produces regulatory supporting documentation for labelling updates.
Provides answers to Regulatory Enquiries related to labelling content, after consultation with senior colleagues.
Provides relevant input into regulatory requests for local label deviations from the Reference Safety Information, in cooperation with relevant Functional Experts (Country Labelling Difference Process).
Other SERM Activities
May assist in review of Safety Data Exchange Agreements, and escalates any deficiencies to the SERM Team Leader to ensure quality and integrity of agreement.
Conducts review/ assist in review of list of studies and identifies TSS/ PASS status in consultation with senior colleagues. Ensures prompt notification to SERM Team Leader of any studies that are identified as potential PASS.
Accountable for maintaining personal readiness in response to internal audit or regulatory inspection.
May act as a member of a process improvement initiative team within the central safety.
Raises concerns/ issues to the line manager in a timely, open and appropriate manner; ensures quality and integrity of issue/ event being escalated.
Expected competencies for this role:
Relevant experience and some autonomy with some supervision required for executing the safety activities related to but not limited to data generation & gathering, data analysis & interpretation, effective prioritisation of tasks and decision making.
Growing ability to confidently communicate with scientific, technical or medical audiences and to tailor information appropriately.
Growing ability to showcase persuasive arguments with stakeholders in a timely manner.
We are looking for professionals with these required skills to achieve our goals:
4 to 9 years of relevant experience
Fluent english and communication skills.
Basic computing skills (to common office applications and familiarity with safety databases).
Good medical/ scientific writing skills.
Good working knowledge of medical and drug terminology.
Good working knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities.
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