Description
Job Location: Great Britain, United Kingdom
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
Job Description Summary:
PTC is committed to providing access to best-in-class treatments for patients with little to no treatment options. This mission underpins our focus on the discovery, development, and global commercialization of clinically differentiated medicines for those with rare diseases. As a patient-centric, global pharmaceutical company, we combine clinical and scientific expertise with groundbreaking science and technology, always with the patient in mind. We work hard to provide broad access to our life-changing treatments. What drives us is our passion to provide patients with more moments with their families.
The Contractor, Pharmacovigilance Operations contributes to PTC’s oversight of the collection, processing, assessment, monitoring and follow-up of Adverse Event (AE) and Serious Adverse Event (SAE) reports from clinical trials and post-marketing sources. This is in compliance with Good Clinical Practice (GCP), and applicable global regulations and guidance documents. The incumbent monitors that AEs and SAEs are processed with a high degree of detail and accuracy and are reported in a timely manner.
He/She is also responsible for monitoring that the Safety Database configuration meets applicable regulations, is kept current with PTC products and studies, and that the vendor provides accurate outputs from the safety database in a timely manner. The incumbent works cross-functionally with internal departments and external resources on ICSR and safety database related matters. The Manager, Pharmacovigilance Operations supports adherence to relevant global regulatory requirements and company SOPs as appropriate.
Primary Duties/Responsibilities:
- Participates in, contributes to implementation & maintenance of robust safety reporting system compliant with current applicable global regulations including closely monitoring PV vendor & case workflow.
- Performs prospective & retrospective QC of cases ensuring ICSR quality; monitors all cases through workflow steps ensuring compliance.
- Supports & participates in training PV vendor on new products/protocols/requirements.
- Reviews/contributes PV vendor documentation including Client Specific Guides & Safety Management Plans.
- Monitors configuration changes of safety database by vendor ensuring they are timely & meet PTC/regulatory requirements.
- Assists in case migrations into safety database monitoring quality/timeliness/documentation audit trail.
- Participates in business continuity arrangements; assists authoring/implementation PV Operations processes.
- Collaborates medical monitor(s), PV leads & Regulatory Affairs monitoring processing/submission/tracking expedited safety reports domestic/international regulatory authorities.
- Supports maintenance/archive manual/electronic drug safety files pertaining ICSR management.
- Reviews quality outputs from safety database for signal meetings/safety summaries for Investigator Brochures (IBs)/Developmental / Periodic Safety Update Reports (D/ PSURs)/Annual Reports.
- Performs other tasks/assignments as needed/specifed by management.
Knowledge/Skills/Abilities Required:
BSN/RN or Bachelor’s degree Biological Sciences or Pharmacy or PharmD degree equivalent; minimum 5 years progressively responsible pharmacovigilance experience pharmaceutical/biotechnology environment including experience within pharmacovigilance operations.
Demonstrated expert knowledge relevant FDA/EU/IHC guidelines initiatives/regulations governing pharmacovigilance; extensive hands-on working knowledge MedDRA terminology/process AEs/SAEs pharmaceutical industry; extensive experience QC/workflow monitoring ensure quality/timeliness case processing; demonstrated ability identify opportunities improve PV reporting process(es); ability influence without direct authority; ability work independently/collaboratively fast-paced matrixed team environment internal/external team members; analytical thinker excellent problem-solving skills/adapt changing priorities/deadlines; excellent planning organization/time management skills support/prioritize multiple projects.
Special Knowledge or Skills Preferred:
Understanding of safety database administration/configuration/data entry/extraction specifically Argus; expertise use Electronic Document Management System (eDMS) software; expertise MedDRA WHODD relevance coding suspect drug/concomitant medications.
Travel Requirements: 0-10%
EEO Statement:
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals regardless race/color/national origin/gender age physical characteristics/social origin/disability/religion/family status/pregnancy sexual orientation/gender identity/gender expression/disability/veteran status any unlawful criterion under applicable law. We are committed treating all applicants fairly avoiding discrimination.
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