SafetyCall International (SCI) is currently seeking an experienced Pharmacovigilance (PV) Specialist to join our growing team remotely from home! This individual will provide PV support for our clients who must comply with post-marketing adverse event (AE) reporting regulations for drugs, dietary supplements and medical devices marketed in the USA and Canada. This support will include quality control, MedDRA coding, case assessments for report-ability and the preparation of regulatory reports prior to delivery to our clients or direct submission to the FDA or Health Canada. The PV Specialist may also be a client liaison (account manager) to an assigned client(s) and will use our pharmacovigilance software, PV-Works.
Essential Duties and Responsibilities
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- Perform duties as SCI’s client liaison and main point of contact to assigned client(s) by providing high levels of customer service and communicating frequently with them to ensure all their needs are being met and communicated back to SCI.
- Complete Individual Case Safety Report (ICSR) quality control (QC) to ensure accurate data collection and appropriate follow-up is completed by the front-line intake call center positions.
- Assess ICSRs for individual adverse event terms signifying seriousness and expectedness relative to the product label while also referencing guidance documents provided by regulatory authorities on assessing seriousness.
- Examine ICSRs for reportability in the USA and Canada and determine the mandatory reporting requirements based on the product classification (e.g. 15-day, 30-day or Periodic).
- Apply appropriate MedDRA terminology and coding to the verbatim AE terms reported within ICSRs.
- Report spontaneous ICSRs to health authorities using pharmacovigilance software.
- Prepare paper documents of the appropriate regulatory forms (e.g. FDA Form 3500A or CIOMS I) for delivery to clients.
- Interact directly with clients on questions they have pertaining to all aspects of ICSR documentation, assessment and regulatory reporting.
- Perform ICSR reconciliation with clients and their marketing partners and exchange safety data when applicable.
- Review literature screening search results, identifying reportable ICSRs and other safety-related findings.
- Write or contribute to the preparation of Periodic Adverse Drug Experience Reports (PADERs) or Periodic Safety Update Reports (PSURs). This may include acting as the project coordinator, collating required information, incorporating reviewers' comments and finalizing the document.
- Assist with required pharmacovigilance processes, supporting preparation of SOPs, product safety reviews and literature reviews.
- Assist with batch data migration between PV databases using the ICH E2B XML transform.
- Participate in all required training and continuing education sessions.
- Maintain a positive, cooperative and respectful relationship with all coworkers.
- Complete other responsibilities and activities as assigned by supervisor and/or SCI partners.
- Maintain regular and punctual attendance.
Other Duties and Responsibilities as Assigned
- Provide initial and ongoing staff training for call center staff and coordinate content efforts and responsibilities with PV staff.
- Provide education conferences and in-services for staff development, coordinating efforts with other staff as needed.
- Assist with or lead other consulting projects as assigned.
- Perform other duties as assigned by management and/or business partners.
Location: Remote from home
Schedule: The Pharmacovigilance Specialist is a full-time, exempt position that will work 5 days/week, Monday-Friday, during normal business hours. The Pharmacovigilance Specialist may need to work hours outside of their normal schedule on occasion to accommodate work load.
Qualifications
- Bachelor’s degree in health or Life Science related field or equivalent pharmacy, nursing or medical experience.
- At least 2 years’ experience working in Pharmacovigilance, a Contract Research Organization (CRO) or other related scientific area.
- Experience writing Periodic Adverse Drug Experience Reports (PADER) or Periodic Safety Update Reports (PSUR) strongly preferred.
- Strong knowledge and experience using computer programs and pharmacovigilance software such as ArisG, Oracle Argus or PV-Works.
- Ability to provide excellent verbal and written communication that is clear, concise, accurate and professional on a regular basis.
- Demonstrated ability to manage multiple and varied tasks and prioritize workload with strong attention to detail.
- Excellent written and oral communication skills with the ability to speak and write in a clear, concise, complete, and persuasive manner on a regular basis.
- Ability to exhibit sound and accurate judgment and make timely and accurate decisions.
- Ability to prioritize and plan work activities in order to be efficient, complete all assigned projects in a timely manner and meet deadlines.
- This position requires initiative, self-motivation, resourcefulness and the ability to work with little direction.
- Strong attention to detail and spelling with the ability to accurately enter data with very few data entry errors.
- Proficiency with keyboarding, navigating PCs, navigating the internet and using common computer software and hardware.
- Experience writing policies and SOPs strongly preferred.
- Demonstrated ability to work effectively independently and in a team environment.
- Ability to gather, analyze, and synthesize complex or diverse information.
Remote Requirements:
Employees must have a space that allows them to work without interruptions or distractions, and must not have any other responsibilities during the time they are working such as caring for animals or dependents. More information about requirements to work from home can be found on our careers page.
Pay & Benefits:
- Pay Range: Variable based on experience and education.
- Benefits include: medical, dental, vision, life, pet and various supplemental insurance options, 401K with match, paid time off, paid holidays, company paid life, short- & long-term disability insurance, CE & license reimbursement, incentive programs, and more!
