Job Description: Summary
Brilliant and rarely available opportunities for physicians with UK Drug Safety experience to relocate to Melbourne, Australia working with an innovative biopharmaceutical company, headquartered in Melbourne but with major facilities in Germany, Switzerland and the U.S. You will be part of a team of physicians and clinical scientists dedicated to PV and risk management of programs from early Phase I to Phase IV.
Company
A global specialty biopharmaceutical company, headquartered in Melbourne, Australia and developing protein-based medicines using core capabilities in plasma therapeutics, vaccines and biotechnological re-combination of genetic material.
Location
South East
Role
(DSP) (SDSP) Clinical Safety Physician
Key aspects of the role are
• Development of safety strategy for a clinical program with contribution to the overall CDP
• Contribution to clinical protocols and investigators brochures as well as the safety sections of development core safety information
• Acting as medical lead on all Phase I safety studies
• Independent safety evaluation of ongoing clinical study data to proactively detect signals of safety issues
• Medical evaluation of clinical study serious adverse events
• Contributing to the establishment and running of Safety Review Committees or Drug Safety Monitoring Boards
• Supporting analyses and interpretation of safety data from completed clinical studies and write or supervise writing of safety sections of clinical study reports, expert reports and medical evaluations for aggregate development safety update reports
• Ensuring that identified safety issues are adequately represented in internal documents such as development risk management plans as well as reporting documents such as annual safety reports
• Formulating the company’s position for regulatory submission documents and responses and contributing to the safety sections of clinical trial or licensing applications
• Representing the company at meetings with regulatory authorities
• Leading the development of risk management plans and support the planning and implementation of pharmacovigilance and risk management strategies
• Leading internal multi-disciplinary Safety Management Teams to proactively identify and critically evaluate potential safety signals arising from clinical studies of drugs in development
• Liaising with licensing partners and consultants
Experience
Candidates must be currently working in the pharmaceutical industry in a pharmacovigilance capacity and have a sound understanding of the principles and practice of Drug Safety. Candidates with Benefit Risk Management experience may also be considered for more senior roles.
Key requirements are
• Excellent communication skills, oral and written
• Ability to assess complex data
• Good organisational skills
• Knowledge and experience of ongoing safety monitoring and signal
• In depth awareness of pharmacovigilance methodology and worldwide clinical safety regulations
• Team player with ability to function in a multi–disciplinary environment
• Self-motivation
• Ability to prioritise and plan effectively
Qualifications
All candidates must be medically qualified and fully registered.
Benefits: Company Car/Allowance:
Bonus:
Pension:
Healthcare:
Life Insurance/Income Protection:
Share Options/Scheme:
Holiday Entitlement:
Other: Relocation assistance
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