Senior Manager - Pharmacovigilance Operations

2 days ago

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Deciphera Pharmaceuticals

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Description

• Senior Manager, Pharmacovigilance Operations leads pharmacovigilance department activities for Deciphera Pharmaceuticals. • This role includes vendor oversight, adverse event management, and regulatory compliance assurance. • Key responsibilities include safety report processing, training support, and cross-functional collaboration.

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

Benefits

• Non-accrual paid time off • Summer vacation bonus • Global, company-wide summer and winter shutdowns • An 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 either health care and/or dependent care. • Family planning benefit • Generous parental leave • Car allowance