Job Description
Job Title: Pharmacovigilance Specialist
Location: Columbus, OH (Onsite, Full-time)
Contract Duration: Minimum 1-year contract
Start Date: ASAP
Job Overview:
We are seeking an experienced Pharmacovigilance (PV) Specialist to join our team. This role requires a strong background in pharmacovigilance, regulatory compliance, and medical writing. The successful candidate will participate in adverse event processing, literature reviews, periodic safety reports, and signal management activities while ensuring compliance with relevant global regulatory requirements. This is a long-term project offering flexible hours.
Key Responsibilities:
- Act as a subject matter expert (SME) in pharmacovigilance, demonstrating a high level of scientific and technical expertise.
- Ensure timely and compliant processing and reporting of adverse events associated with medical nutrition products registered as drugs.
- Maintain documentation and perform quality control checks related to adverse event reporting.
- Oversee and participate in global literature searches, handles processing and maintenance of safety related data found in literature.
- Conduct periodic safety reviews, signal management, and literature-based assessments for inclusion in safety reports.
- Prepare and review aggregate safety data, periodic safety update reports (PSURs), signal reports, and other pharmacovigilance-related documentation.
- Support the development and maintenance of product safety profiles and global pharmacovigilance processes aligned with best practices.
- Ensure compliance with worldwide pharmacovigilance regulations and guidelines.
- Develop an understanding of liquid nutrition and its role within the medical nutrition field.
Qualifications and Preferred Experience:
- Bachelor's degree in a health science-related field required; Master's degree preferred.
- Minimum of 5 years of experience in pharmacovigilance.
- Strong understanding of adverse event reporting, regulatory requirements, and safety data interpretation.
- Experience with medical writing, including the preparation of safety reports, medical assessments, and regulatory documents.
- Prior experience conducting global literature reviews and assessing safety data.
- Hands-on experience with pharmacovigilance regulations
- Exposure to signal management and periodic safety reviews.
- Strong analytical and problem-solving skills with a focus on quality and compliance.
- Ability to communicate scientific and medical data effectively both orally and in writing.
- Preference for candidates with broad pharmacovigilance experience beyond case processing, particularly those with experience beyond CRO environments
Medasource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
Benefits & Perks:
Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee's needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.
Pay Disclaimer:
The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
JO-2501-159718 Medasource
Job Tags
Full time, Contract work, Local area, Immediate start, Worldwide, Flexible hours,