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.Job Description:
Primary duties/responsibilities:
- Participates in, and contributes to, the implementation and maintenance of a robust safety reporting system compliant with current applicable global regulations. This includes closely monitoring the PV vendor and the case workflow.
- Performs prospective and retrospective QC of cases to ensure ICSR quality and monitors that all cases move through the workflow steps to ensure compliance with regulatory timeframes. Supports and participates in training of the PV vendor on new products, protocols, and requirements.
- Reviews and contributes to any PV vendor documentation. This includes but may not be limited to Client Specific Guides and Safety Management Plans.
- Monitors configuration changes of the safety database by the vendor ensuring they are timely and meet PTC and regulatory requirements.
- Assists in case migrations with the vendor into the safety database monitoring quality, timeliness and complete documentation audit trail.
- Participates in business continuity arrangements.
- Assists with the authoring and implementation of PV Operations processes.
- Collaborates with medical monitor(s), PV leads and Regulatory Affairs to monitor the processing, submission and tracking of expedited safety reports to appropriate domestic and international regulatory authorities.
- Supports maintenance and archival of manual and electronic drug safety files pertaining to ICSR management.
- Reviews the quality of outputs from the safety database (or provide if needed) for signal meetings, safety summaries for Investigator Brochures (IBs), Developmental / Periodic Safety Update Reports (D/ PSURs) and Annual Reports.
- Performs other tasks and assignments as needed and specified by management.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
- BSN/RN, Bachelor’s degree in Biological Sciences, Pharmacy or PharmD degree or equivalent and a minimum of 5 years of progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology or related environment, including experience within pharmacovigilance operations.
- Demonstrated expert knowledge of relevant Food and Drug Administration (FDA), European Union (EU) and International Conference on Harmonisation (ICH) guidelines, initiatives, and regulations governing pharmacovigilance.
- Extensive, hands-on working knowledge of MedDRA terminology and the processing of AEs/SAEs in the pharmaceutical industry.
- Extensive experience of QC and workflow monitoring to ensure quality and timeliness of case processing.
- Demonstrated ability to identify opportunities to improve the PV reporting process(es).
- Ability to influence without direct authority.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- *Special knowledge or skills and/or licenses or certificates preferred.
- Understanding of safety database administration, configuration, data entry and extraction, specifically with Argus.
- Expertise in the use of Electronic Document Management System (eDMS) software.
- Expertise in MedDRA and WHODD with relevance to coding suspect drug and concomitant medications.
- Travel requirements
0-10%
EEO Statement:
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
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