Full-Time Sr. Drug Safety Specialist
The primary responsibility of the Senior (Sr.) Drug Safety (DS) Specialist is to collect, accurately document, assess, code and process adverse event reports related to the marketed products monitored by Global Pharmacovigilance (Global PV) within the time frames established by Global PV and in compliance with global regulatory requirements as well as safety partners. In this role, the Sr. DS Specialist will serve as a primary contact point and recipient for adverse events. The Sr. DS Specialist will also manage processing and reporting of serious adverse events received during Mallinckrodt sponsored clinical trials. The Sr. DS Specialist is also responsible for handling related safety inquiries for internal and external customers and will be involved in analysis of safety data for Mallinckrodt Pharmaceutical products. The Sr. DS Specialist will establish and maintain positive and mutually rewarding relationships with all Mallinckrodt personnel involved in PV globally and domestically to ensure global PV compliance. The Sr. DS Specialist will be involved in other tasks for PV as needed and will be cross-trained to handle other functions as deemed necessary.
1. Collect and accurately document adverse event reports.
2. Triage incoming adverse event information for completeness, consistency and seriousness which includes medical evaluation and assessment.
3. Forward adverse event reports, which have been received for book-in to the Mallinckrodt Safety System.
4. Complete processing of adverse events in the Mallinckrodt Safety System ensuring accuracy of event coding, event assessment, medical history and laboratory data as well as composing the written narrative.
5. Review individual adverse event reports to ensure cases meet Mallinckrodt quality standards before approving for submission to regulatory bodies and safety partners.
6. Prepare and submit Expedited reports to regulatory authorities including obtaining the appropriate medical review.
7. Review the results of all medical literature searches for any individual case safety reports or potentially relevant safety information.
8. Perform query for adverse event reports as required (verbally, email, in writing).
9. Ensure compliance with safety data exchange agreements with safety partners.
10. Execute searches in the Mallinckrodt Safety System as required.
11. Provide support during regulatory authority inspections, safety partner audits, internal audits, etc.
12. Review aggregate data for emerging safety issues, Periodic Safety Update Reports, etc.
13. Distribute PV data and information to Quality, Legal, Regulatory Affairs or other departments as needed.
14. Conduct trend analyses in order to provide alert to changing safety and efficacy profiles on regular and ad hoc basis as defined by manager or requested by management or internal customers.
15. Elevate potential safety signals and alert appropriate management personnel when needed.
16. Initiate and coordinate investigations as necessary with Product Monitoring Department.
17. Attend seminars to stay current with relevant global regulatory requirements and guidances regarding Pharmacovigilance and drug safety.
18. Work in conjunction and effectively communicate with Product Monitoring, Medical Information, Regulatory Affairs, International Regulatory, Clinical Operations, Sales, Legal, Marketing, Quality Assurance and other department personnel.
19. Participate in team activities concerned with the safety, development or support of products as necessary.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
1. Other duties as assigned with or without accommodation.
2. Maintain or hold an inactive professional licensure in accordance with State and Federal Laws.
• Minimum of a Bachelor’s degree in medical, pharmacy or life-sciences degree required
• Healthcare certification is a plus (i.e. RN, RPh, PharmD, Physician’s Assistant, Nurse Practitioner, Respiratory Therapist, etc.).
Experience: A minimum of 5 years’ experience with post-marketing and/or clinical adverse events in the pharmaceutical industry including experience with a safety database. Clinical/practical experience in a relevant clinical environment required. Thorough knowledge of global Pharmacovigilance regulations and guidelines.
• Knowledge of the clinical areas for which Mallinckrodt markets products.
• Knowledge in the review and analysis of the medical literature.
• Demonstrable skills in reviewing and summarizing medical records.
• Fluency in written and oral English is essential in order to facilitate communications with Pharmacovigilance and Patient Safety, Regional Medical and other headquarters functions
• Fluency in written and oral local language a requirement in order to facilitate communications within the affiliate medical department, and with the National Regulatory Authority.
• Strong experience in computer applications such as Microsoft Word, Excel, Microsoft Access, and Power Point, and a willingness to expand and increase competencies.
• Extensive experience in the reporting as well as managing of adverse event reports.
• Experience in writing safety summaries.
Committed, self-motivated team player
Exceptional problem solving skills
Ability to meet the demands of a position in a dynamic organization
Ability to operate independently by planning, scheduling and arranging activities in accomplishing objectives.
Ability to meet internally and externally required deadlines
Outstanding organizational abilities
The Sr. DS Specialist reports directly to the Director, Pharmacovigilance Operations and will operate independently under limited supervision and will participate in determining work objectives. Throughout the processing of adverse events, the Sr. DS Specialist will work closely with members of global PV, Regulatory Affairs, Clinical Operations, Medical Information, Product Monitoring and Legal.
Normal office environment
Occasional travel will be required for professional training seminars, workshops, and conferences and off-site business meetings.
How to ApplyIf interested and qualified, please visit the link below to apply: https://mallinckrodt.wd5.myworkdayjobs.com/MallinckrodtCareers/job/US-Specialty-Brand-Headquarters---USA501/Senior-Drug-Safety-Specialist_JR000010152-1
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