Pharmacovigilance (PV) Specialist
About the position 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 Rhythm’s safety vendor. This position will report to the Director of Pharmacovigilance.
Responsibilities
- 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 oversight 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 quality review of SAEs and SUSARs from clinical trials 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 all adverse event data.
- Actively participates in cross functional projects that develop and support strong cross-functional relationships and communication.
- Maintains knowledge of adverse event reporting process and safety system and contributes to the development, improvement and standardization of new processes and methods.
- As an individual contributor, may serve as project lead for PV projects.
- Undertakes activities necessary to be inspection ready.
- 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.
Requirements
- Bachelor’s degree in nursing, pharmacy, or other life sciences required. Master’s 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 make initial clinical judgement and seek medical oversight on a wide area of topics, both to internal and external stakeholders
Benefits
- A discretionary annual bonus may be available based on individual and company performance.
- This role may be eligible for benefits and other compensation such as restricted stock units.