Job Description
Salary:
Role Overview
The Pharmacovigilance Manager is responsible for supporting all PV activities for the company, including case management, medical Information inquiries, aggregate reports, SDEAs, communication with PV vendors and business partners, CAPAs & Deviations and partner audits. The Pharmacovigilance Manager participates in, and contributes to, the implementation and maintenance of a robust safety reporting system compliant with current applicable global regulations.
Primary Duties & Responsibilities
pharmacovigilance and support the development and implementation of necessary PV procedures
Qualifications
Education: Degree in Pharmacy or Life Sciences required with strong Pharmacovigilance experience
Languages: English Required, Spanish fluency is a plus
Experience (years/area) : 5-7 years of experience in a pharmacovigilance role, experience with safety databases such as ArisG or Argus preferred, medical information or medical affairs knowledge is a plus, Experience with EDC clinical trial systems (e.g. Medidata Rave, ClinTrak, Veeva Vault), CRO with small-mid pharma is strongly recommended
Specific Knowledge: Ability to diagnose and troubleshoot basic technical issues , knowledge of FDA, EMA, and ICH pharmacovigilance guidelines and the ability to interpret and apply applicable regulations, In-depth knowledge of the Drug Development process, signal detection, and regulatory affairs, working knowledge of MedDRA and WHO Drug, and knowledge of Post marketing surveillance activities and clinical trail case processing
Requirements and personal skills
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job functions.
While performing duties of this job, employee is regularly required to be at a desk and have basic mobility in the office. The position also requires the employee to understand the speech of another person via phone or in person and speak clearly for listeners to understand.
Travel: 0-10%
Position Type and Expected Hours of Work: This is a full-time position. Days and hours of work are Monday through Friday, 9:00 a.m. to 5 p.m., onsite according to company policy.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee:
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