PV Senior Associate/Manager, Drug Safety and PV Operations

Proclinical, in support of our client, are seeking an individual to fill the role of PV Senior Associate/Manager of Drug Safety and Pharmacovigilance Operations, based in Cambridge, MA. Reporting to the Associate Director/Director of Drug Safety and Pharmacovigilance Operations, the successful candidate will play a key role in drug safety operations across the clinical development program, and will contribute to the day-to-day operational activities of the department.

Responsibilities

• Participate in the daily management and execution of DS and PV operations.
• Monitor compliance with regulations, PV agreements and internal SOPs.
• Represent Drug Safety and Pharmacovigilance on clinical development teams.
• Provide sponsor oversight of SAE processing by outsourced vendors.
• Identify problems and track them to resolution.
• Ensure the implementation of effective corrective and preventative action plans.
• Provide timely and objective feedback to outsourced vendors on SAE quality and compliance.
• Implement metric-based scoring system to objectively measure outsourced vendor performance.
• Maintain PV Intelligence for SAE reporting.
• Provide safety operations support for external submissions, signal detection and risk management planning activities.
• Ensure compliant exchange of safety data between Blueprint Medicines and its partners.
• Participate in the quality management system in Drug Safety including ensuring department standards are met.
• Collaborate with contract service providers for case processing, aggregate reporting and quality management activities.
• Manage the performance of PV systems.
• Participate in regulatory inspections and company audits.

Skills And Qualifications

• BA/MA/Doctorate in healthcare related profession or life sciences preferred and 2+ years of experience in drug safety/PV in an industry setting or equivalent.
• Experience working with CROs, vendors, and relationship management preferred.
• Global PV operations experience with products in development.
• Safety database, MedDRA coding and data entry experience preferred.
• Knowledge of FDA and EU legislation and ICH Efficacy guidelines preferred.
• Strong written, verbal, and interpersonal communication skills, with a focus on technical writing and presentation.

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 Brandon Zheng at (+1) 646-851-0869 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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