Senior Manager - Pharmacovigilance Operations

3 days ago

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

⏰ Full Time

🟠 Senior

⚙️ Operations

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Deciphera Pharmaceuticals

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Deciphera Pharmaceuticals is a biotechnology company dedicated to defeating cancer by developing innovative kinase inhibitors to improve patient outcomes. The company focuses on designing switch-control kinase inhibitors to address mechanisms of tumor and drug resistance, aiming to enhance treatment responses for patients with cancer. Deciphera has a diverse pipeline of drug candidates, including ripretinib and vimseltinib, and is committed to making a significant impact on the lives of cancer patients. As of June 2024, Deciphera is a wholly-owned subsidiary of ONO Pharma and continues to work on improving human health through its scientific innovations and patient-centric approach.

201 - 500 employees

Founded 2016

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• The Senior Manager, Pharmacovigilance Operations encompasses a key leadership role in providing direction to the Pharmacovigilance department for adverse event case management, support of study teams and projects, oversight of maintenance of drug safety database, and collaboration to support risk management and pharmacovigilance for all Deciphera Pharmaceuticals Clinical Trials and post marketing (where applicable). • Responsible for performing critical safety vendor oversight to ensure all pharmacovigilance activities are performed in an efficient, consistent and compliant manner. • Accountable for coordination of day-to-day operational ICSR activities in collaboration with designated management personnel at the vendor site(s). • Review incoming adverse events to determine action required. • Provide oversight and review of vendor case processing and submission activities by external vendor, including the review and monitoring of compliance through various monitoring reports and other oversight activities. • Manage Vendor Oversight including tracking of KPIs, metrics and QC of SAE / ICSR cases in Safety database. • Responsible for facilitation of training, including training GVP Modules and key relevant US & EMA safety-related Guidance documents and procedures and development of vendor personnel (remotely and on-site at the vendor site) as required, driving the development of self-sufficiency at the vendor. • Lead Deciphera Pharmaceuticals PV Operations in ensuring all safety reports received from all clinical trials are processed in a consistent and a fully compliant manner. • Manage SAE / SUSAR reporting activities for all investigational drugs (Maintain oversight to ensure Global clinical trials case reporting process is efficient and compliant with reporting requirements). • Oversee maintenance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events from Deciphera Pharmaceutical clinical trials. • Provide direct technical /data management support to ensure information entered and retrieved from the safety database is consistent, accurate and complete in accordance to data requests. • Performing and contributing to safety monitoring and signal detection activities for products including signal identification, evaluation, interpretation of safety signals and prioritizing signals for full evaluation and communication of safety risks. • Perform ad hoc analyses as required. • Ensure Global clinical trials case reporting process is efficient and compliant with reporting requirements detailed in the safety management plans (SMP) / PV agreements. • Support the oversight and management of global business partner safety data exchange agreements/ pharmacovigilance agreements and other contracts as applicable to ensure compliance with data exchange activity. • Communicates with partner companies and vendors regarding processing and timely exchange of safety data. • Distributes aggregate reports as required and assists with reconciliation activities. • Develop and maintain Medical Safety and Pharmacovigilance related documents including Safety Management Plans, SOPs and Work Instructions, and Safety Data Exchange Agreements. • Lead preparation of safety-related plans with partners and CROs. • Provide guidance and support to project teams for safety-related areas, including protocol development and study conduct. • Work cross functionally with Regulatory Affairs and Quality Assurance functions to maintain current knowledge of regulatory safety reporting guidelines and implementing relevant guidelines into Deciphera practices and procedures. • Contribute to preparation of relevant safety sections of clinical study reports, annual reports, expedited safety reports and other regulatory filing documents. • Assist as needed with the preparation and updates to Investigator Brochures, DSURs, Protocols, ICFs, IBs (including RSI determination), CSRs, CCDS, RMP, REMS etc. • Assist with response to safety-related queries from regulatory authorities or Ethics Committees, if needed. • Collaborate to ensure alignment among case handling, aggregate reporting, and signal detection activities. • Assist with the ongoing review TFLs and AE data from ongoing studies to evaluate common AEs, lab abnormalities, and summarize the results in the product safety reports in support of regulatory submission activities, signal detection and management activities, or in response to ad hoc safety inquiries from health authorities, track all safety related activities. • Support the development of Deciphera Pharmaceutical PV infrastructure, including new safety projects and set-up of safety systems applicable to safety data from the medical and scientific perspective. • Oversee deviation and CAPA activities in relation to, but not limited to, late SUSAR or aggregate report submissions as well as deviations relating to case management processes as defined per the SMPs or SOPs. • Adhere to company policies and applicable regulations including reporting of adverse events to regulatory agencies. • Other duties as assigned.

🎯 Requirements

• Bachelors/Advanced degree preferably in life science, nursing, pharmacy or other healthcare related profession (MD, RN, PharmD, NP, PhD, MPH, etc.) • 6+ years of direct pharmacovigilance work experience in the pharmaceutical industry • Experience with Argus Safety database is a must • Solid understanding and working knowledge of US and ex-US pharmacovigilance regulatory requirements (e.g., US Code of Federal regulations; European Union GVP legislation; and ICH Guidelines) • ICSR submission experience is highly preferred • Knowledge of MedDRA and WHO Drug dictionaries • Experience with overseeing and managing vendors • Experienced in pre- and post-approval pharmacovigilance activities, including safety reporting • Solid clinical knowledge and strong analytical ability to review, evaluate, interpret, and synthesize clinical and safety data • Strong proficiency in verbal and written communication; great attention to detail, ability to meet project deadlines • Ability to work independently, to manage work priorities, to build collaborative team relationships at all levels and remain flexible to the needs of the teams / projects. • Must be able to work on multiple projects simultaneously • Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures • Proficient in standard computer software (Word, Excel and Power point presentations) • Previous experience and formal training with safety database programs including configuration and validation activities is preferred.

🏖️ Benefits

• Competitive salary and annual bonus. • Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more. • Generous parental leave and family planning benefits. • Outstanding culture and opportunities for personal and professional growth.