Consultant Medical Director, Drug Safety Pharmacovigilance
Proclinical is currently recruiting for a Consultant Medical Director or Drug Safety Pharmacovigilance for a biotechnology company located in Cambridge, MA. Successful candidate will be responsible for and recognized as the go-to person for the safety strategy throughout the product lifecycle for assigned marketed and development products.
- Medical safety review of all available safety data generated from various sources throughout the product life cycle for assigned products.
- Conduct signal activities, including monitor, evaluate, interpret, manage and communicate safety information.
- Lead the Product Safety Teams for assigned products and manage benefit-risk profiles along with the related actions, including writing and updating of the benefit-risk documents for assigned products and development compounds.
- Medical expert safety review of and input into all critical documents for assigned products in clinical development.
- Collaborate with the Head of Safety to develop and implement the strategy for benefit-risk management for assigned products.
- Author important medical content of Risk Management documents (e.g., RMPs, REMS)
- Write periodic reports for assigned products and provide medical interpretation, review and approval for required reports where applicable.
- Provide expert safety input into clinical development programs for assigned products.
- Provide the medical safety content for responses to inquiries from regulatory authorities related to safety topics and integrated safety input into any applicable regulatory documents where required.
- Provide Drug Safety input for individual product quality complaints, aggregate product quality associated Health Hazard Evaluations, product recall issues and Dear Healthcare Professional letters/communications.
- Review scientific literature for assigned products, identify case reports that meet criteria for entry into the safety database; identify relevant safety articles / references involving the active ingredients of the assigned products; and create literature summary sections for PBRERs/PSURs and other required reports.
- Represent Global Drug Safety on leadership committees and related activities both internally and externally as required.
Skills and Requirements:
- MD Degree required.
- Minimum of 4 years of clinical experience as a practicing physician.
- Minimum of 5-7 years pharmacovigilance drug safety experience including benefit/ risk analysis and safety evaluations.
- Expert knowledge of FDA regulations, GVP in the EU, ICH guidelines, and other applicable regulatory guidance documents required.
- Experience with pharmacovigilance audit and regulatory inspection processes.
- Ability to write SOPs and other working practices and documents within the context of clinical and post-marketing drug safety reporting.
- Familiarity with common adverse event management databases (e.g. Argus) Knowledge of MedDRA and WHO Drug coding dictionaries.
- Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way Comprehensive experience with obtaining, analyzing, disseminating, and reporting safety information in compliance with safety regulations, including periodic safety reports.
- Excellent verbal and written communication skills, including formal presentations. Proficiency in Microsoft Excel, PowerPoint and Word required.
- Sound organizational skills with the ability to prioritize tasks.
- Excellent interpersonal, team management and leadership skills.
- Prior experience in interactions with regulatory authorities on drug safety aspects as well as risk management strategies and pharmaco-epidemiology.
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.
Proclinical Staffing is an equal opportunity employer.