Job Description
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
- Review of individual case safety reports (ICSR) ensuring that adverse event reports are processed in a timely manner, in accordance with the appropriate company SOPs, study protocols, and within regulatory timelines
- Utilize clinical and scientific expertise to respond to medical information inquiries from health care professionals, patient/consumers, field staff, internal business partners and other customers
- Monitor scientific literature for potential adverse event reports and send them for case processing within established timeframes
- Track and report any regulatory authorities or business updates impacting pharmacovigilance and support the development and implementation of necessary PV procedures
- Collaborates with case processors, PV vendors, PV leads, and Regulatory Affairs to monitor the processing, submission and tracking of individual case safety reports from all sources to appropriate authorities.
- Review aggregate safety reports such as periodic adverse drug experience reports (PADERs), DSURS PSURs/PBERS
- Provide PV input to clinical study documents: protocols, safety management plan, informed consent forms, case report forms, protocol amendments, and study reports
- Ability to perform quality review of clinical trial SUSARs, SAEs, AESI processed by team
- Ensures adequate training and team development within US pharmacovigilance team
- Monitor and maintain high regulatory compliance, author individual CAPAs for non-compliance.
- Support and lead audit/regulatory inspections and work closely with GPV and other stakeholders in implementation of CAPAs following the audit/inspections.
- Authoring, review and implementation of PV SOPs
- Communicate with business partners in preparing safety data exchange agreements.
- Research and draft responses to inquiries from patients, healthcare professionals, and internal stakeholders in the form of FAQs and Standard Response Letters.
- Maintain inspection readiness and support GVP audits and inspections
Qualifications
Education: Bachelor's degree in Biological Sciences. RPh, Pharm.D, RN is a plus
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, experience in medical information or medical affairs, Experience with EDC clinical trial systems (e.g. Medidata Rave, ClinTrak, Veeva Vault)
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
- Excellent verbal and written communication skills, ability to convey moderately complex technical information clearly to others
- Sound knowledge of Microsoft Office applications
- Excellent organizational ability and attention to detail
- Ability to work independently, take initiative in identifying issues and presenting solutions
- Uncommon flexibility and ability to manage simultaneous priorities, changing deadlines, and limited resources
- Actively engage in process enhancement by identifying inconsistencies, inefficiencies and offering a fresh perspective on targeted issues
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:
• Is required to interact with internal and external contacts independently
• Is regularly required to talk or hear either in person or over a dial tone phone, as well as a mobile phone, when applicable.
• Is often required to stand, walk, bend, lift, or sit.
• Is desk-based and may be sitting for long periods of time.
• Must regularly use fingers and hands for fine manipulation: typing, writing, using hand-held device (iPad, laptop, cell phone, keyboard, printer)
• Must communicate clearly: phone calls, emails, in-person conversations
Must possess ability to make sound decisions, process complex information, manage multiple tasks simultaneously, model behavior for other employees, and other cognitive functions.
Job Tags
Full time, Monday to Friday,