Manager, Drug Safety and Pharmacovigilance
Proclinical is currently recruiting for a Manager of Drug Safety and Pharmacovigilance with a biopharmaceutical company located in Princeton, NJ. Successful candidate will act as the supportive liaison between pharmacovigilance/life cycle safety vendor(s) partnering with the company to ensure serious adverse event processing adheres to all global Regulatory requirements and internal SOPs, SMPs, etc.
- Manage drug safety/PV Vendors to ensure all internal and external timelines are met, potential issues are communicated, and resolution is achieved in a timely manner.
- Maintain multiple internal tracking documents related to clinical trial and post-marketing SAE processing.
- Closely monitor clinical trial and post-marketing case processing from receipt to case closure including query generation, narrative writing, data review and make accurate determination of significant information and identify and initiate requests for case follow up.
- Conduct complete review and assessment of all SAE reports. Ensure consistency in the initial evaluation and assessment of SAE reports and source documentation, prepare MedWatch, CIOMS, and other forms, as needed.
- Oversee SAE reconciliations for multiple studies, identify cases requiring investigator letters and draft investigator letters independently.
- Responsible for reviewing and developing Drug Safety/Pharmacovigilance SOPs and Word Instructions and ensure safety operations follow the most current US and global regulations.
- Contribute to the development of risk management plans and REMs if needed. Support safety surveillance/pharmacovigilance activities.
- Review and revise safety-related sections in study protocols, periodic reports, Regulatory Agency submission documents.
- Review and revise SMPs, applicable SOPs and related forms.
- Assist in the preparation of safety sections for regulatory documents (e.g. DSUR, PBRER/PSUR).
- Review and process contracts and change orders.
- Participate in signal detection and signal management activities.
- Ensure all safety-related documentation is properly filed (e.g. in the TMFs and the safety files).
- Organize/participate in periodic Safety data review meetings (DSMBs, internal).
- Maintain a high level of understanding of applicable Regulatory regulations (FDA and ICH guidance, GCP regulations; EU Directives, PVG Modules, etc) to assist in ensuring all requirements are adhered to.
- Interact with other departments (e.g. Regulatory Affairs, Clinical Operations and Data Management, QA, and when required, Site Personnel) to ensure all safety reports are completed and submitted in time and in accordance with internal SOPs and external Regulatory reporting timelines.
Skills and Requirements:
- BS/MS or equivalent in a health care field or RN (with course work in clinical research preferred) or demonstrated equivalent experience necessary to fulfill position requirements.
- 5+ years' pharmaceutical or CRO experience in a clinical research or clinical trial project management role, 3 years of which are in a drug safety and pharmacovigilance role. Candidates with less than 5 years of experience will be considered if he/she has an advanced degree in a medical field.
- Understanding of the nature and work requirements associated with industry regulations related to this role.
- Ability to work independently with little supervision, self-motivation is a must.
- Operate with a sense of urgency and ability to continuously reprioritize.
- Ability to manage multiple activities simultaneously.
- High degree of attention to detail and organization.
- Ability to write concisely and cogently.
- Complete required documentation in an accurate and efficient manner.
- Follow-up in a timely manner.
- Ability to work with investigational site staff in a professional, productive fashion.
- Excellent interpersonal skills, work within a matrix environment and interact/communicate effectively across various levels within the organization when needed.
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.