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Senior Manager, PV Operations

Constellation Pharmaceuticals, Inc.

This is a Full-time position in Cambridge, MA posted July 16, 2021.

DescriptionConstellation Pharmaceuticals is a pioneering epigenetics company, focused on the discovery and development of novel, small molecules targeting chromatin regulatory proteins in tumor and immune cells for therapeutic applications in oncology. We believe that each team member has the ability to impact and improve the lives of patients. We are #BrighterTogether!The Senior Manager will play a key role in the PV Operations across the Global Clinical Programs; provides leadership through managing the operational activities both internally and externally through PV Vendors related to the collection, processing and review of AEs from clinical trials and ensures that performed tasks comply with SMPs, SOPs, best industry standards and applicable regulations.In this role you will:* Execute PV Operational strategy for safety data collection, processing and review across all programs* Develop, implement, improve and standardize new processes, methods, and databases* Collaborates with Clin. Ops and Investigative sites to ensure complete and accurate event reporting* Oversee the set-up of safety aspects of new clinical trials including study-specific Safety Management Plans and Periodic Reporting Plans* Provide clinical trial safety oversight and support including the support of database lock clean-up activities for AEs/clinically significant laboratory values* Manage the third-party PV Vendor outsourced Clinical Trial Safety activities* Provide sponsor oversight of PV Vendor’s SAE processing including the review and monitoring of compliance and other oversight activities and ensures the implementation of effective CAPAs* Ensure compliant exchange of safety data between Constellation and its partners* Ensure the timely preparation, review and submission of aggregate safety reports* Provide support for external submissions, signal detection and risk management planning activities* Monitor compliance with regulations, PV agreements and internal SOPs* Prepare governing documents, such as SOPs, Work Instructions and Safety Management Plans* Collaborate with Medical Affairs personnel on Investigator Sponsored programs as required* Perform PV quality management system activities including training requirements, monitoring performance, implementing continuous improvement actions and good documentation practice* Work with QA department to maintain a state of PV inspection readiness across all regions/countries* Participate in internal audits and global regulatory inspections including MHRA/FDA/EMA etc. as a SME for specific PV topics and processesWe are looking for people with:* Bachelor’s degree in healthcare or life sciences* Minimum of 5 years of experience in Drug Safety/Pharmacovigilance in a pharmaceutical industry setting or the equivalent* Minimum of 3 years of experience working with PV vendors, CROs, and business alliance relationship management* Global PV operations experience with products in development preferred* Knowledge of relevant ICH, EMA and FDA Guidance and Regulations governing AE processing and reporting from clinical trials preferred* Experience working with Safety databases and systems (Argus preferred)* 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 organizationConstellation Pharmaceuticals recognizes the value of diversity in our workforce. We are committed to equal opportunity. We consider all qualified employment applicants without regard to race, religion, color, gender, age, national origin, sexual orientation, gender identity, partnership status, protected veteran status, disability, or any other status protected by federal, state, or local law. Individuals who hold legal work authorization applicable to employment at Constellation Pharmaceuticals in the United States will be considered without regard to citizenship/alienage. Constellation Pharmaceuticals is a participant in E-Verify.Basic QualificationsPreferred Qualifications