3 Pharmacovigilance Specialist Jobs in Boston, MA
Rhythm Pharmaceuticals is Hiring a Pharmacovigilance Specialist Near Boston, MA
Opportunity OverviewAs 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 newly created position will report to the Associate 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 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 AD as indicated.
- Performs other activities as required.
- 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 the 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
Job Summary
Full Time
Pharmaceutical
$92k-132k (estimate)
06/08/2024
07/06/2024
rhythmtx.com
BOSTON, MA
50 - 100
2008
DAVID MEEKER PRES-CEO
$5M - $10M
Pharmaceutical
Related Companies
About Rhythm Pharmaceuticals
Rhythm is a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity. The company is leveraging the Rhythm Engine -- comprised of its TEMPO Registry, GO-ID genotyping study and Uncovering Rare Obesity program -- to improve the understanding, diagnosis and potentially the treatment of these disorders. For healthcare professionals, visit www.UNcommonObesity.com for more information. For patients and caregivers, visit www.LEADforRareObesity.com for more information.
The following is the career advancement route for Pharmacovigilance Specialist positions, which can be used as a reference in future career path planning. As a Pharmacovigilance Specialist, it can be promoted into senior positions as a Drug Safety/Medical Information Specialist IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Pharmacovigilance Specialist. You can explore the career advancement for a Pharmacovigilance Specialist below and select your interested title to get hiring information.
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