Director, Medical Safety
Proclinical is currently seeking a Director of Medical Safety/Pharmacovigilance for a biopharmaceutical company located in South San Francisco, CA. Successful candidate will report to the VP, Drug Safety and Pharmacovigilance and will work collaboratively within the Drug Safety and Pharmacovigilance department, across departments, and with partner companies to achieve PV and company goals.
- Performing signal detection activities to ensure signal identification and evaluation.
- Participating in safety surveillance strategy and activities for all investigational products, including development and implementation of relevant policies and procedures.
- Conducting medical review of individual case safety reports.
- Collaborating with partners on safety monitoring and signal detection activities; participating in establishing and maintaining Safety Data Exchange Agreements.
- Collaborating, contributing to, and reviewing relevant sections of clinical and regulatory documents.
- Contributing to the creation and maintenance of Reference Safety Information, and the safety sections of Investigator Brochures for all investigational products.
- Reviewing and summarizing scientific literature relevant to pharmacovigilance on assigned projects.
- Participating in inspection readiness activities and preparation as needed.
- Staying current with international pharmacovigilance requirements and guidelines.
Skills and Requirements:
- MD or equivalent, Pharm D, or advanced degree in nursing.
- 8+ years of drug safety experience (with 5+ years managing medical case review and signal.)
- Strong knowledge and understanding of international safety reporting and pharmacovigilance requirements and signal detection.
- Ability to take initiative yet work collaboratively on multiple projects and with partner
companies to achieve goals in compliance with PV and regulatory requirements and safety data exchange agreements.
- Excellent written and oral communication skills.
- Excellent interpersonal skills and ability to work effectively as part of a team(s).
- Experience in neurology and/or cardiovascular drug development desirable.
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 Yannick Dada at (+1) 646-741-8433 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.
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