Pharmacovigilance Operations Lead

6 days ago

Watertown, Massachusetts, United States Deciphera Pharmaceuticals Full time
About Deciphera Pharmaceuticals

We are a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer. Our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology enable us to develop a broad portfolio of innovative medicines.

Job DescriptionSenior Manager, Pharmacovigilance Operations

This role encompasses key leadership responsibilities for providing direction to the Pharmacovigilance department, encompassing 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).

  • We are seeking an experienced leader to oversee critical safety vendor oversight to ensure all pharmacovigilance activities are performed efficiently, consistently, and compliantly.
  • The successful candidate will be accountable for coordination of day-to-day operational ICSR activities in collaboration with designated management personnel at the vendor site(s), reviewing incoming adverse events to determine action required.
  • Oversight and review of vendor case processing and submission activities by external vendors, including compliance through various monitoring reports and other oversight activities, is also a key responsibility.
  • The ideal candidate will facilitate training, including GVP Modules and key relevant US & EMA safety-related Guidance documents and procedures, and drive 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 consistently and fully compliantly. Manage SAE / SUSAR reporting activities for all investigational drugs, maintaining 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 with data requests.
  • Perform ad-hoc analyses as required and contribute 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.
  • 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.
Qualifications
  • A Bachelor's or Advanced degree preferably in life science, nursing, pharmacy, or other healthcare-related profession (MD, RN, PharmD, NP, PhD, MPH, etc.).
  • At least 6 years of direct pharmacovigilance work experience in the pharmaceutical industry.
  • Experience with Argus Safety database is mandatory.
  • 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, manage work priorities, build collaborative team relationships at all levels, and remain flexible to the needs of the teams/projects.
  • 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 PowerPoint presentations).
About the Role

This position offers a comprehensive compensation package, including an estimated salary of $120,000 - $150,000 per annum, commensurate with qualifications and experience. Benefits include paid time off, summer vacation bonus, global company-wide shutdowns, annual lifestyle allowance, monthly cell phone stipend, internal rewards and recognition program, medical, dental, and vision insurance, 401(k) retirement plan with company match, life and supplemental life insurance for family, short and long-term disability insurance, health savings account with company contribution, flexible spending account for healthcare and/or dependent care, family planning benefit, and generous parental leave.

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