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Senior Manager, Pharmacovigilance
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At Proclinical, we are seeking an individual to fill the role of Senior Manager of PV Science - Global Patient Safety and Risk Management, based in Boston, MA. The successful candidate will be responsible for supporting the development and implementation of a risk management system and will oversee risk management plan activities.
Responsibilities
- Work with the safety physician to analyze potential issues.
- Collaborates with all internal and external vendors to apply knowledge and analytical skills to problems in specific therapeutic areas.
- Coordinate and develop Risk Management Plans (RMPs) for products among multiple stakeholders. Participate in the collection and analysis of data related to status and measurement of the effectiveness of risk management initiatives.
- Responsible for patient safety evaluation and development of Safety Management Plans.
- Contribute to signaling and data mining activities utilizing internal and external sources of data.
- Develop knowledge of capabilities and limitations of various data sources.
- Assist in the evaluation of potential safety issues and quality risk assessment reports.
- Contribute to activities related to the functioning of safety committees.
- Contribute to the development of SOPs, work practices and guidelines, forms and templates, and other communications related to risk management and product safety.
- Ensure the global team can anticipate, develop and support improved/consistent scientific ways of working to implement effective pharmacovigilance processes.
- Contribute to scenario planning, strategy analysis, portfolio prioritization, budget management and forecasting.
- Manage and support the authoring for aggregate safety reports.
- Support development and application of business process improvement methodologies and/or developing ideas into practical business solutions.
- Provide management and training for new staff on Scientific Enablement practices and therapeutic area knowledge.
Skills And Qualifications
- MD/PharmD/RN or high, relevant qualification and 5+ years of pharmaceutical industry experience.
- Ability to manage teams and to work in a matrix environment in accordance with the company leadership commitments and values. Preferably with experience of working across diverse geographic areas, business settings and cultures.
- Pharmacovigilance, safety or clinical science, and/or other relevant areas of clinical biopharmaceutical development or medical affairs.
- Extensive knowledge of Argus, Arisg Safety Databases and signaling tools (Empirica, Spotfire).
- Advanced knowledge of global Pharmacovigilance regulatory requirements.
- Strong written, verbal, and interpersonal communication skills.
- Experience in clinical patient care a plus.
To Apply:
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) 6467418433 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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