SafetyCall International (SCI) is currently seeking a full-timePharmacvogilance (PV) Specialist to work in our Bloomington office or remote from a home office. Candidates who live in Minnesota outside of the Twin Cities area or in the following states are eligible for remote from home positions: Arizona, Colorado, Florida, Georgia, Illinois, Kansas, Michigan, Nebraska, Nevada, North Carolina, North Dakota, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin. Remote staff must be able to train in our home office in Bloomington, Minnesota for a 2-3 week period and meet the IT requirements described below. The company will reimburse for lodging and travel expenses for the training period if applicable.
The Pharmacovigilance (PV) Specialist is responsible for providing pharmacovigilance support for SafetyCall (SCI) clients who must comply with post-marketing adverse event (AE) reporting regulations for drugs in the USA. 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 PV specialist will use our pharmacovigilance software, PV-Works. The PV Specialist will act as a resource for other staff on matters pertaining to pharmacovigilance and are expected to lead by the mission, vision, values and principles of SCI in order to support and advance the company.
Essential Duties and Responsibilities
Perform Individual Case Safety Report (ICSR) quality control (QC) to ensure accurate data collection by the front-line intake call center according to SOP and ensure that appropriate follow-up is completed
Assess individual adverse event terms within ICSRs for seriousness and expectedness relative to the product label and guidance documents on assessing seriousness provided by the regulatory authorities.
Assess ICSRs for report-ability 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
Interact directly with clients pertaining to questions they have pertaining to all aspects of ICSR documentation, assessment and regulatory reporting.
Assure compliance with safety data exchange agreements between SafetyCall clients and their marketing partners.
Perform ICSR reconciliation with clients and marketing partners of clients and exchange safety data when applicable.
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 report coordinator, collating the needed information, incorporate reviewers' comments and finalizing the document.
Educate client representatives about regulatory requirements and be a resource for partner agreements.
Participate in all required training and continuing education sessions.
Maintain a positive, cooperative and respectful relationship with all coworkers.
Maintain regular and punctual attendance.
Perform other duties as requested by supervisor or partners.
Schedule: The PV Specialist will regularly work Monday-Friday during normal business hours (9am-5pm CST) with some occasional evening, weekend and holidays as needed.
Pharmacy (PharmD) Degree and active Pharmacy License OR Associates or Bachelor’s in Nursing and active Registered Nursing License.
Experience working in Pharmacovigilance, Contract Research Organization (CRO) or other related scientific area focused on capturing human health data in a software database is preferred
Knowledge and experience using computer programs, particularly patient management software or and pharmacovigilance software such as ArisG, Oracle Argus or PV-Works is preferred.
Maintain confidentiality of clients’ products, procedures, and case detail as well as SCI’s operating procedures.
Ability to manage multiple and varied tasks and prioritize workload with strong attention to detail.
Ability to work effectively independently and in a team environment to meet deadlines.
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 to 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.
Remote Agent Requirements:
Candidates who work remotely must have or be willing to obtain and maintain at their expense certain IT requirements including a land line telephone with the ability to connect to a headset (cell phones cannot be used), reliable high speed internet with an ISP that can supply a cable modem internet service with a minimum of 20mb download speed, desktop or laptop computer with Windows 10 and the capability to display two monitors (no Mac). Candidates must also have a designated home office area that meets certain requirements and may not have any other responsibilities during the time they are working such as caring for dependents.
SCI offers competitive pay and a comprehensive benefits package, a fun work environment with many perks including casual dress and complimentary onsite fitness center, experience in a fascinating field, and the ability to work from home for qualified candidates.
We highly suggest that interested candidates visit our website, www.safetycall.com, and view our company overview video. Interested candidates should submit their resume and a cover letter or introductory e-mail to email@example.com. Our team will review each submission and contact the candidates that most closely match the qualifications.
Additional Salary Information: Medical, Dental, Vision, Life, Accident and Pet insurance options available, 401k with match, paid time off, paid holidays, CE/License reimbursement and many more!
Internal Number: n/a
About SafetyCall International
Safetycall International is a 24/7 multidisciplinary health care practice that provides manufacturers in various industries with adverse event management, regulatory reporting services, post-market surveillance, customer service and consulting services nationally. Our staff includes pharmacists, toxicologists, veterinary toxicologists, nurses, emergency medical technicians/paramedics, pharmacy technicians, health information specialists, veterinarians, certified veterinary technicians, regulatory specialists and other trained professionals.