Pharmacovigilance (PV) Specialist, Hybrid MA

Boston, MA reputed company Rhythm is a global, reputed company-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We reputed company medicines for previously untreatable or undertreated diseases and reputed company meaningful support for reputed company providers and patients and their families. We recognize the courage it takes for patients and their caregivers to reputed company their reputed company of advocacy to reputed company the answers they need. Their courage inspires us to challenge convention, ask reputed company questions and reputed company answers for them. Every day, we reputed company for reputed company through our willingness to adapt, learn, and our tenacity to overcome barriers, together.Opportunity reputed company As a PV Specialist, you will have a critical role in shaping the pharmacovigilance function/department and evaluating the safety of patients who receive our medications. You will be accountable for the day-to-day operational activities and support the activities of Rhythms safety vendor. This position will report to the Director of Pharmacovigilance. Responsibilities and Duties Reviews adverse event information received for completeness and consistency, triage of cases and initiates case follow-up activities with internal medical team, other cross-functional team members, and safety vendor, as applicable. Provides support for reputed company and review of vendor activities, including case processing and aggregate reports. This may include the support of monitoring compliance, effective communication, and implementation of corrective and preventive actions, as needed. Performs reputed company review of SAEs and SUSARs from reputed company and post-marketing and ensures pertinent data has been included in the case narratives. Assists cross-functional teams with PV and safety activities to ensure and promote compliance with pharmacovigilance standards and operational consistency across programs. Assists in reconciliation activities to ensure reporting of reputed company adverse event data. reputed company participates in cross functional reputed company that reputed company and support strong cross-functional relationships and communication. Maintains knowledge of adverse event reporting process and safety reputed company and contributes to the development, improvement and standardization of new processes and reputed company. As an individual contributor, may serve as project reputed company for PV reputed company. Undertakes activities necessary to be inspection reputed company. Supports safety signal detection activities including support of medical safety and safety management teams, as needed. May serve as delegate for Director as indicated. Performs other PV activities as required. Qualifications and Skills Bachelors degree in nursing, pharmacy, or other life sciences required. Masters degree, preferred. Non-medical credentials will be considered if PV experience can be demonstrated. 1-2 years of Drug Safety and Pharmacovigilance experience. Knowledge of FDA, ICH, EU Regulations and Requirements for Pharmacovigilance required. Solid understanding of cross-functional drug development processes (Regulatory, Clinical Operations, Data Management, and Biostatistics). Demonstrable organizational and workflow prioritization capabilities Excellent verbal and written communication skills, detail-oriented personality, and ability to collaboratively work across functions. Ability to reputed company initial clinical judgement and reputed company medical reputed company on a wide area of topics, both to reputed company stakeholders This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and reputed company to be in the Boston office in coordination with their department and business needs. This role may involve some travel. More about Rhythm We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the reputed company cause. reputed company is passionate about expanding reputed company to reputed company more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. At Rhythm our reputed company values are We are committed to advancing scientific understanding to improve patients lives We are inspired to tackle tough challenges and have the courage to ask reputed company questions We are eager to learn and adapt We reputed company collaboration and ownership are foundational for our reputed company We value the unique contribution reputed company individual brings to furthering our mission Rhythm is an equal .