Remote Medical Director, Pharmacovigilance and Drug Safety
Proclinical is currently recruiting for a Director of Medical Safety for a clinical-stage biopharmaceutical company. Successful candidate will be responsible for developing a highly strategic and compliant Pharmacovigilance function.
- Managerial oversight of the Medical Safety function.
- Global signal detection and signal management, monitoring, evaluation, interpretation and supports appropriate management.
- Drive the strategy for medical input and risk-benefit assessment to periodic reports.
- Assure processes are in place and appropriate for decision making around risk-benefit profile, risk minimization, etc.
- Support mentoring and training on the implementation and execution of safety practices including, risk management, signal management, throughout the product lifecycle.
- Lead creation and updating of Company Core Safety Information (CCSI), Reference Safety Information (RSI) and safety portions of other labeling.
- Provide expert safety input to the clinical development program for assigned projects.
- Provide senior PV Leadership with ongoing updates of the changing risk-benefit profile of products in development and marketed products, provide appropriate safety actions and risk mitigation plans.
- Response to inquiries from regulatory authorities on safety issues.
- Integrate safety input into all regulatory documents, where required.
- Represent Medical Safety in PV leadership team.
- Ensure communication of all Global PV and safety issues to Senior PV Management.
- Develop and maintenance of applicable Standard Operating Procedures.
- Maintain inspection continuous readiness.
Skills and Requirements:
- MD or equivalent required.
- 5-10 years' Safety/Pharmacovigilance experience within pharmaceuticals or biotechnology.
- Experience in pre-marketing setting, additional experience in post-marketing setting is preferred.
- Global experience is preferred.
- Thorough understanding of pharmacovigilance regulations and guidelines esp. FDA, EMA, and ICH.
- Working knowledge of MedDRA including SMQs.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Brendan Dunn at (+1) 646-481-1930 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.