Job type full-time
Not provided by employer
Full job description
Job description summary: the contract, 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 sourcesThis is in compliance with good clinical practice (gcp), and applicable global regulations and guidance documentsThe 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 contract, pharmacovigilance operations supports adherence to relevant global regulatory requirements and company sops, as appropriate job description: essential functions primary duties/responsibilities:
Participates in, and contributes to, the implementation and maintenance of a robust safety reporting system compliant with current applicable global regulationsThis 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 timeframesSupports and participates in training of the pv vendor on new products, protocols, and requirements.
Reviews and contributes to any pv vendor documentationThis 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.
Minimum level of education and years of relevant work experience.
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.
Special knowledge or skills needed and/or licenses or certificates required.
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.
Proficiency with microsoft office.
Excellent verbal and written communication and skills.
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.
**at ptc therapeutics we are seeking candidates in the united states who are fully vaccinated against covid-19 or who will be fully vaccinated by the time they begin the positionEeo statement: ptc therapeutics is an equal opportunity employerWe 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 lawWe are committed to treating all applicants fairly and avoiding discrimination.
Posted 19 days ago