Vice President, Pharmacovigilance
Proclinical is currently recruiting for a Vice President of Pharmacovigilance for biopharmaceutical company located in Cambridge, MA. Successful candidate will lead the strategic management, planning, and execution of Clinical Pharmacovigilance and risk management for early and late stage clinical development programs in compliance with the appropriate regulatory guidelines.
- Organize and oversee product safety surveillance and evolving safety profiles for clinical development of our products.
- Review and approve drug safety information from clinical sources in accordance with WHO-ICH guidelines and the appropriate regulatory agencies, including FDA.
- Develop and implement SOPs and other controlled documents to support investigational and marketed product safety surveillance.
- Identify and analyze safety signals emerging from individual or aggregate safety event analyses: perform aggregate analyses of specific events across studies, as indicated.
- Monitor CRO performance to ensure optimal safety assessment and reporting of ongoing clinical trials.
- Oversee investigational and/or approved drug safety updates, investigational new drug safety reports, investigator communications, Development Safety Update Reports (DSURs) and other reports as necessary.
- Oversee the PV group's development and communication of periodic (e.g. quarterly) comprehensive cross-therapeutic area internal safety reviews with responsibility for identification and interpretation of any new safety signals on an ongoing basis.
- Participate on cross-functional product/project teams including review of safety sections of protocols, investigator brochures, informed consent forms, marketing documents, and other documents providing safety content.
- Develop and implement Pharmacovigilance training programs for both internal and external use.
- Liaise with Medical Research, Clinical Operations, Regulatory Affairs and Quality to ensure appropriate and timely communication/dissemination of safety information to internal members and external stakeholders.
- Implement, execute, and maintain safety processes and systems.
Skills and Requirements:
- MD degree in a health science, with relevant clinical experience.
- Previous management or project management experience.
- 8-10+ years' total experience in US and/or international pharmacovigilance/drug safety, or equivalent relevant clinical development experience in Pharmaceutical and/or Biotechnology industry.
- Expert knowledge of domestic and international regulatory safety reporting requirements, including FDA/ICH guidance's related to pharmacovigilance (e.g.E2B) and Good Clinical Practices, as well as working knowledge of Code of Federal Regulations regarding drug safety.
- Ability to achieve compliant solutions to complex problems in which analysis of situations or data requires an in-depth, strategic evaluation of various factors.
- Must have excellent, concise writing skills, excellent communication and interpersonal skills, and experience in working in multidisciplinary teams.
- Demonstrated leadership skills and ability to influence across external functions and within internal team.
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.