Senior Director, Safety Evaluation and Risk Management
Our client is a global biotechnology company focused on improving the lives of people with cancer. They have asked us to assist them in their search for a Senior Director, Safety Evaluation and Risk Management
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Represents the Global Safety Risk Management on the Clinical Sub Team for assigned products.
- Provides expert medical guidance regarding safety matters and issues.
- Performs/provides oversight for medical review of individual safety reports from clinical trials or post-marketing sources.
- Contributes to the preparation and review of periodic reports.
- Participates in protocol development, ensuring alignment with risk management plans.
- Reviews and provides medical content, as needed, for key study-related documents.
- Contributes to the analysis of safety data from on-going and completed clinical trials and presentation in Clinical Study Reports.
- Facilitates the production and maintenance of risk management plans and safety communication to regulatory agencies or third parties.
- Participates in continuous improvement activities including systems design, performance measurement and quality management.
- Provides guidance and mentorship to staff.
- Contributes to Pharmacovigilance agreements and interactions.
- Participates in alliance safety teams with external partner(s).
- A medical degree with board certification or ex-US equivalent is required.
- Requires a minimum of 3 years of Director level experience in Drug Safety, Clinical Safety, Pharmacovigilance or Risk Management.
- Oncology safety science experience is preferred.
- Knowledge of ICH, US and EU regulations and requirements for pharmacovigilance is required.
- Experience with world-wide safety reporting regulations and guidelines is required.
- Must have excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally.
- Must have excellent written and spoken English.
- Prior experience with business partners is preferred.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.