PV Operations Manager

ProClinical is currently seeking a PV Operations Manager for a pharmaceutical company located in Cambridge, MA. Successful candidate will be reporting to the Associate Director/Director of Drug Safety and Pharmacovigilance Operations, the Project Manager of Drug Safety and Pharmacovigilance Operations. Additionally, the candidate will play a key role in drug safety operations across the clinical development programs. PV Operations Manager DSPV contributes to the day-to-day operational activities of the department and ensures that performed tasks comply with DSPV SOPs and policies, best industry standards and applicable regulations.

Job Responsibilities

• Participating in the daily management and execution of DS and PV operations.
• Monitoring compliance with regulations, PV agreements and internal SOPs.
• Representing Drug Safety and Pharmacovigilance on clinical development teams, as assigned.
• Providing sponsor oversight of SAE processing by outsourced vendors, including the review and monitoring of compliance through various monitoring reports and other oversight activities.
• Identifying problems, issues and taking ownership of them, and tracking them to resolution.
• Ensuring the implementation of effective corrective and preventative action plans.
• Providing timely and objective feedback to outsourced vendors on SAE quality and compliance.
• Implementing metric-based scoring system to objectively measure outsourced vendor performance and report to management.
• Maintaining PV Intelligence for SAE reporting in all the client's territories.
• Providing safety operations support for external submissions, signal detection and risk management planning activities.
• Ensuring compliant exchange of safety data between the client and its partners.

Skills and Requirements

• BS in nursing, pharmacy, or other health care related profession or life sciences preferred.
• MS/MA/PhD in health care related profession preferred, but not essential.
• Experience working with CROs, vendors, and relationship management preferred.
• Global pharmacovigilance operations experience with products in development.
• Strong analytical and problem-solving skills with superb attention to detail.
• Strong verbal, written technical communication and presentation skills.
• Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization.
• Proven ability to work within a cross-functional, matrixed team.

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 [CONSULTANT NAME] at […] 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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