Contract - Medical Director, Pharmacovigilance
Proclinical is currently recruiting for a Medical Director of Pharmacovigilance for a pharmaceutical company located in Waltham, MA. Successful candidate will perform the assessment of medical safety information including single cases and aggregate safety data for developmental and marketed products.
- Perform medical review of individual case safety reports (ICSRs) including the determination or confirmation of case reportability criteria, and the assessment of seriousness, expectedness and causality. Request missing medical information as needed.
- Lead aggregate safety data reviews and contribute to the preparation of the medical content of periodic (including PSURs, DSURs) and ad-hoc reports. Review the safety sections of relevant labeling documents, identify and lead updates as required.
- Lead regular and ad-hoc cross functional safety review teams. Represent pharmacovigilance on other multi-departmental projects.
- Prepare and ensure the quality, consistency, and timely delivery of safety information for regulatory submission documents (including IND and NDA submissions). Author relevant sections of responses to safety related health authority requests.
- Author and/or review relevant sections of various clinical documents e.g. Investigator's Brochures, clinical protocols, safety management plans, study reports, and integrated analyses.
- Develop and maintain general safety signal management methodologies and product specific strategies.
- Guide and train pharmacovigilance colleagues on medical assessment, signal detection and safety risk management practices.
- Identify opportunities and participate in continuous improvement initiatives as related to medical assessment of pharmacovigilance data.
- Actively interact with external customers and service providers including business partners, CROs, system vendors and the call center.
- Lead or contribute to the development and/or updates of relevant procedural documents including SOPs, Work Instructions, conventions, forms or templates.
- Provide medical safety expertise for internal and external audits and regulatory authority inspections for Pharmacovigilance and ensure that relevant corrective actions are implemented.
- Maintain an up-to-date working knowledge of applicable regulatory requirements, guidelines, and industry standards globally.
Skills and Requirements:
- MD required.
- 2+ years of experience in clinical practice or in academic medicine.
- 3-5+ years of experience in pharmacovigilance including medical review, signaling and safety risk management.
- Demonstrated ability to analyze and present complex pharmacovigilance data, experience with authoring medical evaluations and contributing to regulatory submissions.
- Strong competency in understanding the scientific background of disease mechanisms and medical therapies.
- Understanding of global pharmacovigilance regulatory requirements and guidance documents.
- Ability to influence decision making around multifaceted issues involving medical safety.
- Proficiency in the use of Windows, MS Office and other relevant cloud based applications.
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.