Safety Science Director

Hobson Prior are looking for a Safety Science Director to join a leading pharmaceutical organisation who are focused on researching and developing pioneering products to enable patients to live longer and fuller lives.

Job Responsibilities:

• Provide high level scientific expertise in the safety evaluation and risk management of key assets or other highly complex products in clinical development and/or the post- marketing setting.
• Accountable to ensure that adverse event and other safety information is efficiently evaluated in order to meet global compliance and regulatory requirements, identify the need for product labelling updates and drive proactive implementation of risk management initiatives.
• Provide global leadership of safety evaluation and risk management activities throughout the product's entire life cycle and shows confidence, credibility and influence at all levels of the organisation and, possibly, externally to the organisation.
• present the disease area or product area safety strategy at key internal meetings, and fully represents the organisation externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners.
• You may deputies for the PV Team Leader.
• May also participate in, or lead, cross-activities such as safety advisory panels, interfaces with high levels of the organisation outside CH SERM on a regular basis and may be recognized as a key player in external international pharmacovigilance activities.

Key Skills:

• Excellent evaluation skills and analytical thinking.
• Outstanding medical writing skills.
• Sound computing skills.

Requirements:

• Degree in Biomedical or Health Care related speciality
• Expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities.
• Expertise in causality assessment, evaluation of safety signals and proactive risk management strategies including management of labelling changes, physician and patient education.
• In depth knowledge of other related disciplines, e.g. statistics, epidemiology relevant to assessing drug utilization and safety at the population level.
• In depth knowledge of medical and drug terminology and a sound foundation in pharmacology.
• In depth knowledge of clinical development process.
• A strong understanding of drug approval process in major countries.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.