Location(s): United States; Massachusetts; Marlborough
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Role Summary: The Pharmacovigilance (PV) Scientist provides assistance to the Pharmacovigilance Physician in the management of adverse event (SAE) reporting from clinical trials, and prepares various regulatory documents within agreed time frames and to a high standard of accuracy, in compliance with GE Healthcare business rules, standard operating procedures and global and local regulatory requirements.
Essential Responsibilities: Responsibilities include, but are not limited to the following:
Clinical trial safety and SAEs
Contribute to definition of safety reporting requirements in clinical study protocols and Safety Management Plans.
Contribute to expectedness lists for development and marketed products in clinical studies.
Support PV physician in review of SAEs and non-serious adverse events from interventional clinical and from non-interventional post-marketing studies. Contribute to Analysis of Similar Events (AOSE).
Provides assistance to case processing team in data entry of clinical trial SAEs into Argus safety database and to medical coding of adverse events and diseases.
Reviews literature database output for suspected safety issues from the medical literature.
Assists PV Physician in organizing and leading Safety Management Team (SMT) / Safety Review Team (SRT) meetings.
Provides support in compilation of information for reference safety information (including Company Core Safety Information) and investigator's brochure.
Aggregate reports and responses to questions
Prepares aggregate Reports including Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), Safety Summary Reports, and US Periodic / Annual Reports.
Prepares ad hoc responses to regulatory authorities in response to specific queries from regulators.
Prepares responses to inquiries from internal sources, health care professionals, and other external sources.
Bachelor’s degree in nursing, pharmacy or related field.
At least 5-7 years of pharmaceutical and/or biotechnology industry or relevant service provider experience, including experience in preparing clinical trial safety management plans and aggregate reports.
Hands-on experience in case processing of clinical trial SAE cases and preparation of AOSE.
Strong working knowledge of applicable regulations and international guidelines.
Experience in developing case series retrieval strategies.
Experience in pharmacovigilance writing and review of aggregate reports, responses to questions, narratives, follow-up requests.
Experience with coding according to the Medical Dictionary for Regulatory Activities (MedDRA).
Ability to travel domestically and internationally.
Excellent written and verbal communication skills, exceptional listening skills, strong presentation skills, and good negotiating and influencing skills.
Quality Specific Goals:
Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
Complete all planned Quality & Compliance training within the defined deadlines.
Identify and report any quality or compliance concerns and take immediate corrective action as required
Ability to speak more than one language.
Ability to work collaboratively with PV Physicians in all pharmacovigilance-related activities.
High integrity, sense of urgency, ability to recognize time sensitivity, willingness to work in a matrix environment, willingness to work independently and with team members in different locations and time zones.
Knowledge and understanding of safety database search strategies to support the Pharmacovigilance Physician in the identification and evaluation of safety signals.
Experience in Argus safety database.
Basic understanding of data mining in the evaluation of safety signals.
Locations: United States; Massachusetts; Marlborough
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