Job Description: Summary
Opportunities for physicians with regulatory or pharmaceutical industry experience in a clinical safety environment to relocate to Australia. Developing safety strategies and conducting ongoing safety monitoring and risk management for clinical research projects from early Phase I development to Phase IV, you will be responsible for global development safety plans, pharmacovigilance strategy and detecting safety signals to present integrated data in documents for regulatory submission.
Company
A speciality biopharmaceutical company with more than 90 years’ experience developing new important biotech medicines for serious medical conditions is offering excellent relocation packages to fill permanent roles at its HQ. Employing more than 9000 people in 27 countries, the company is rapidly expanding its development portfolio, creating exciting new opportunities in clinical R&D.
Location
Melbourne, Australia
Role
(DSP) Clinical Safety Physicians
Key aspects of the roles
• Development of the safety strategy for a clinical program with contribution to the overall clinical development plan
• Contribution to clinical protocols and investigators brochures as well as the safety sections of development core safety information
• 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
• Leads 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
Coupled with a sound background in clinical medicine and preferably encompassing Cardiovascular, Immunology or Haemato-Oncology medicine, applicants must have clinical safety or development experience and be fully aware of pharmacovigilance methodology and global safety regulations.
Key requirements are
• Excellent written and verbal communication skills
• Ability to evaluate, interpret and synthesize scientific data
• Capability to self-start
• Team player with ability to function in a multi–disciplinary environment both independently and in cross-functional teams
• Self-motivation with ability to prioritise and plan effectively
Qualifications
All candidates must be medically qualified and fully registered.
Benefits: Bonus:
Pension:
Healthcare:
Life Insurance/Income Protection:
Share Options/Scheme:
Holiday Entitlement:
Other: Generous relocation package
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