Clinical Safety Risk Lead
Are you a Physician or Safety Risk Specialist looking for an exciting new job opportunity?
We are currently looking for a Clinical Safety Risk Lead to join a leading Biopharmaceutical company.
As the Clinical Safety Risk Lead you will be responsible for performing proactive Safety Surveillance (SS) and Risk Management with focus on signal detection and evaluation, risk assessments and safety risk minimization.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Clinical Safety Risk Lead will be varied however the key duties and responsibilities are as follows:
You will be responsible for acting as a Point of Contact for Safety in the Asset Teams as well as providing disease area specific pharmacovigilance expertise and applying this to various business unit products assigned to the SRL.
The Clinical Safety Risk Lead will perform ad hoc special scholarly Safety Surveillance & Risk Management activities, contribute to review and development of intradepartmental policies and procedures as appropriate and make decisions based on clinical experience.
You will also assess the suitability of biopharmaceutical products on typical physician practice within various health systems, hospital and non-hospital patient care facilities.
Another responsibility will be to provide suitable summaries of product risks to summary document authors where appropriate, for example providing medical content/B-R statements and overall risk messaging of the safety profile to WMS/PSSR Authors.
It will be crucial to provide guidance and/or oversight to SSRM colleagues on safety issues and provide formal and informal education to other SSRM colleagues on key safety and pharmacovigilance topics.
To be successful in your application to this exciting opportunity as the Clinical Safety Risk Lead we are looking to identify the following on your profile and past history:
The ideal candidate will hold a Doctor of Medicine (Physician) degree.
Proven industry experience in medical (e.g.
patient care, clinical trial experience/investigator, academic medicine, speciality training and/or board certification) and/ or scientific, and/or pharmacovigilance and/or drug development is required.
A working knowledge of Pharmaceutical industries organizational structure, policies, and practices, as applicable to safety Risk Management is ideal for this role.
Degree qualifications within DVM (veterinarian), PharmD (pharmacist) or PhD will also be considered for this role along with a thorough understanding of Safety Risk Management internal and external environment, including applicable regulations and guidances.
Key Words: Risk Management | Safety Risk Lead | Drug Development | Pharmacovigilance | Biopharmaceutical | Medical Doctor | Physician | Veterinarian | Pharmacist | Clinical Trials |