Manager, Pharmacovigilance (PV) Operations
ProClinical, in support of our client, are seeking an individual to fill the role of Manager of Pharmacovigilance (PV) Operations, based in Boston, MA. The successful candidate will be a creative, resourceful, and integrative thinker who will work on and processes that ensure the strategies of the department are executed within global safety legislation and requirements.
- Review and execute PV Operations safety data collection strategy.
- Provide oversight and review of vendor case processing activities.
- Participate in cross-functional activities to ensure and promote compliance with pharmacovigilance data collection standards and operational consistency.
- Provide knowledge into Clinical and Post Marketing teams on the needs and timelines of organized data collection.
- Participate in the creation and dissemination of appropriate safety reporting language.
- Accountable for reconciliation activities between Global Patient Safety and Post Marketing programs.
- Participate in projects that develop and support strong cross-functional relationships and communication.
- Maintain knowledge of adverse event reporting process and safety system and contributes to the development, improvement and standardization of new processes and methods
- Contribute to projects which involve the implementation of new processes and methods within and across Global Patient Safety.
- Undertake activities necessary to maintain a state of inspection readiness
- Provide sponsor oversight of SAE processing by outsourced vendors, including the review and monitoring of compliance through various monitoring reports and other oversight activities and ensures the implementation of effective corrective and preventative action plans.
- Participate in the quality review of SAEs and SUSARs following data entry by vendor.
- Represent Drug Safety and Pharmacovigilance on clinical development teams, as assigned.
- Participate in internal audits and global regulatory inspections including MHRA/FDA/EMA etc. as a SME for specific PV topics and processes.
Skills and Qualifications
- BA in a health care related profession or life sciences required. MA in same preferred.
- 5-7 years of Drug Safety and Pharmacovigilance experience and vendor management experience.
- Knowledge of FDA, ICH, EU regulations and requirements for Pharmacovigilance.
- Experience using ARISg, Argus or other Safety Database applications required.
- Strong written, verbal, and interpersonal communication skills.
- Strong proficiency in Microsoft Office suite.
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.
£0.00 - £70000.00 per annum
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