SafetyCall International (SCI) is currently seeking an experienced Pharmacovigilance/Medical Device Regulation (PVMDR) Specialist to join our growing team! This individual will be responsible for providing pharmacovigilance support for SafetyCall (SCI) clients who must comply with post-marketing adverse event (AE) reporting regulations for drugs and medical devices 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 deliver to our clients or direct submission to the FDA or Health Canada. The PVMDR Specialist will use our pharmacovigilance software, PV-Works.
Candidates who live in the following states are eligible for a full time remote work arrangement: Arizona, Colorado, Florida, Georgia, Illinois, Kansas, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Mexico, North Carolina, North Dakota, Oklahoma, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin. We are not able to consider candidates living in states other than those listed here.
Essential Duties and Responsibilities
- Complete Individual Case Safety Report (ICSR) quality control (QC) to ensure accurate data collection and appropriate follow-up is completed by the front-line call center.
- 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 for serious assessments.
- 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.
- Perform duties as outlined in SCI’s Client Liaison job description as assigned. The Client Liaison is the main point of contact to assigned client(s) by providing a high level of customer service and communicating frequently with the client(s) to ensure all their needs are met and communicated back to SCI.
- 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.
- Participate in all required training and continuing education sessions.
- Maintain a positive, cooperative, and respectful relationship with all coworkers.
- Maintain regular and punctual attendance.
- Complete other responsibilities and activities as assigned by supervisor and/or SCI partners.
This position is in a professional office setting or remote from home.
Schedule: The PVMDR Officer is a full-time, exempt position that will work 5 days/week, Monday-Friday.
Training: Due to COVID-19, training will be completed remote from home. When it is again safe to do so, some travel to our office in Bloomington, MN may be required.
Other Duties and Responsibilities as Assigned
- Provide initial and ongoing staff training for call center staff and coordinate content efforts and responsibilities with Health Information Specialist staff.
- Provide education conferences and in-services for staff development (i.e. Morbidity & Mortality conferences), coordinating efforts with other staff as needed.
- Assist with or lead other consulting projects as assigned.
Required Experience, Skills, Knowledge and Abilities
- Pharmacy (PharmD) Degree and active Pharmacy License OR Bachelor’s in Nursing and active Registered Nursing License.
- Experience working in pharmacovigilance or medical device safety, a Contract Research Organization (CRO) or other related scientific area focused on capturing human health data in a software database is preferred.
- Experience writing Periodic Adverse Drug Experience Reports (PADER) or Periodic Safety Update Reports (PSUR) is preferred.
- Experience writing policies and SOPs is preferred.
- Strong knowledge and experience using computer programs, particularly patient management software or pharmacovigilance software such as ArisG, Oracle Argus or PV-Works is preferred.
- Understanding of SCI’s call center operations, SOPs and policies.
- Understanding of SCI’s core services, how to read proposals, addendums, etc.
- General understanding of SCI clients, industries, and their regulatory requirements.
- Maintain confidentiality of clients’ products, procedures, and case detail as well as SCI’s operating procedures.
- Demonstrates effective group presentation skills.
- Demonstrated self-motivated work ethic
- Demonstrated professionalism while representing SCI in business or social settings.
- Customer service focused attitude and behavior.
- Demonstrated ability to effectively work independently and in a team environment.
- Verbal and written communication that is clear, concise, accurate, professional, empathetic, persuasive and compassionate on a regular basis, including during stressful or high-pressure situations and interactions.
- Ability to gather, analyze, and synthesize complex or diverse information.
- 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.
- Can quickly adapt to changes in workflow, policies and procedures and encourages others to do so.
- Above average proficiency with keyboarding, navigating PCs, navigating the internet and using common computer software and hardware
Why Work Here?SCI is a 24/7 multidisciplinary health care practice, licensed by the boards of Medicine, Pharmacy, and Veterinary Medicine, that provides manufacturers with adverse event management, regulatory reporting, post-market surveillance, customer service and consulting services. Pet Poison Helpline (PPH) is a 24-hour animal poison control service for pet owners and veterinary professionals who require assistance with treating a potentially poisoned pet. We encourage all applicants to view our company overview videos at www.petpoisonhelpline.com and www.safetycall.com.
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