Proclinical is advertising a vacancy for a Brand Insights Manager vacancy with a leading international pharmaceutical company that specialises in multiple therapy areas. This prestigious organisation is seeking for the Brand Insights Manager to join their team in Massachusetts.
They will manage and provide direction for expedited reporting requirements and process for global ICSR reporting and distribution to Regulatory Authorities, LOCs, Alliance partners, CROs, and Ethics Committees in collaboration with Global Standards and Compliance. The Brand Insights Manager will also execute the business processes and development of procedures and tools to facilitate efficient operations compliant reporting of ICSRs to regulators, LOCs, and internal and external partners and vendors.
Job Responsibilities:
- Providing leadership and oversight to vendors performing ICSR submissions, ensuring adverse event information is processed according to company timelines and quality standards.
- Managing and overseeing requirements for global ICSR reporting and distribution to Regulatory Authorities, LOCs, Alliance Partners, CROs, and Ethics Committees.
- Ensuring the accuracy of safety system configuration against the reporting requirements.
- Communicating and collaboration with Global PV functions and regulatory intelligence to assist with seamless systems for compliant reporting to Health Authorities.
- Overseeing regulatory submissions for ICSRs from the Global Safety database, on-time delivery of adverse event reports to Global Health Authorities, alliance partners, LOCs, ECs, vendors, and investigators; developing and implementing a methodology for regular quality assessments.
- Overseeing and managing communication with alliance partners, vendors, CROs, and internal partners regarding the evaluation and processing of ICSRs.
- Representing Global Pharmacovigilance Operations in internal audits and Health Authority inspections related to global expedited reporting and submissions.
- Reviewing Alliance Partner safety data exchange agreements requirements.
- Ensuring overall performance of the department and compliance with global regulatory requirements by implementing appropriate SOPs, processes, and by reporting reference materials and metrics.
- Monitoring performances, accuracy, compliance, and training on Global Expedited Reporting and Submissions at a global level.
- Leading PV relationships with the PV BPO Vendor and/or vendors performing PV Processes and Global Expedited Reporting and Submissions to ensure compliance with SLAs.
- Supporting LOCs in PV tasks responding to queries and requests regarding case handling and expedited reporting.
- Managing vendor oversight procedures.
Skills and Requirements:
- At least a bachelor's degree in a scientific/medical field, with an advanced degree preferred.
- At least 8 years of pharmaceutical or health care related industry experience.
- At least 6 years of PV experience with 4 years of experience working with CROs, vendors, and relationship management.
- Global experience with CROs, vendors, and relationship management preferred.
- Experience with matrix management and well-developed skills in teambuilding, motivation and developing people.
- Demonstrable interpersonal skills, including communication, negotiation, persuasion, partner relationship management, collaboration, and consensus decision making.
- Strong critical thinking and analysis skills, including the ability to make key decisions.
- Excellent knowledge of PV regulations for the global pre-and-post market.
- Experience with safety databases, including search and code dictionaries and performing expedited E2B reporting to regulatory authorities.
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 Kevin Cassini on +1 215 531 5288 or upload your CV 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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