Pharmacovigilance Manager

Who We Are

Theradex Oncology is a full-service CRO, conducting early- and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease.

What You'll Do

Theradex is currently recruiting for a Pharmacovigilance Manager (Full time/Permanent/ Hybrid).

The primary responsibilities of this position include, but are not limited to, the following:

• Set overall policy and priorities for the pharmacovigilance unit for the quality and compliance of all PV deliverables. • Collaborate with PV leadership to set up and maintain an efficient PV system in compliance with U.K. and E.U. regulations • Gather information or assign tasks or activities for a given project. • Maintain PV expertise and understanding of international safety regulations andguidelines • Maintain knowledge of investigational products • Prepare study specific Safety Management Plans SMPs and Data and Safety Monitoring, Plans, defining roles and responsibilities of each party involved in clinical safety data flow and processes. • Contribute to study specific PV training materials, safety SOPS, work instructions and other study specific safety documents in collaboration with other PV and clinical team members. • Manage the processes of initial and follow-up SAE reports according to Theradex® or Sponsor SOPs, the Safety Management Plan, or equivalent, and ICH guidelines. Review SAE reports and any supporting documents for accuracy and completeness and manage the preparation of SAE reports for assessment by the Medical Monitor for relatedness and expedited reporting. • Collaborate with Medical Monitor for aggregate safety data review activities and coordinate safety surveillance activities. • Coordinate the review of safety data by the Medical Monitors at pre-determined intervals • Serve as a key liaison between the Clinical team, Sponsor, and third party vendors for the management of adverse event reports for clinical studies • Ensure a timely submission of pharmacovigilance reports (SUSARs and other safety communications) to regulatory authorities, ethics committees and investigators • Contribute towards ongoing assessments of the safety of the product • Notify the Sponsor of SAEs, as required, and follow-up with the investigational site personnel and CRA(s) to address queries for completing the SAE Report Form, medical assessment and reconciling the Theradex® SAE and clinical databases. • Prepare safety reports (MedWatch/CIOMS) for Sponsor approval, regulatory submission and investigator notification. • Reconcile the Theradex® SAE and clinical databases and coordinate with data management and CRA to resolve discrepancies. • Work in collaboration Global Clinical team to maintain the pharmacovigilance section of the Trial Master File to ensure sections related to clinical safety are accurate and up to date. • Maintain study specific records for SAEs and safety reports, including the Theradex® SAE database. • Ensure direct reports training records are up to date, including SOPs. • Participates in training, audit and inspection support • Contribute to Continuous Improvement Initiatives Develops PV goals, continued compliance and strategy for process improvement initiatives with senior management

What You Need

Level of Education

Bachelor’s or Masters’ degree in pharmacy, nursing or in a life science field or equivalent, Medical background preferred.

Prior Experience

1-2 years Drug Safety experience or related (preferred)

5 years prior experience inclusive of prior clinical research/pharmacovigilance experience (required)Prior experience in oncology preferred

Skills and Competencies

Thorough understanding of internal SOPs of Theradex Oncology and of specific sponsor/clients.

Thorough knowledge of current European Union, and United Kingdom legislation and regulatory. Requirements as outlined in EudraVigilance and/or any other applicable guidelines related to pharmacovigilance. Knowledge of U.S. and Canadian requirements is a plus.

Detailed and thorough knowledge and application of ICH-GCP requirements

Knowledgeable of MedDRA and WHO-DD Coding

Ability of prioritizing tasks in order to meet deadlines, multitasking and working well under pressure.

Highly developed leadership skills

Excellent communication skills (both written and oral)

Proficient computer skills (minimum: Word, Excel and PowerPoint)

Highly effective ability to set and meet personal short- and long-term goals

Highly effective ability to anticipate problems relating to projects and to develop and implement solutions

Strong analytical, problem solving and technical skills

Creates a learning environment, is approachable and available.

Excellent interpersonal skills

Highly organized and result-oriented

Ability to work independently as well as in a team environment

Fluent knowledge of written and verbal English

Experience of working with ARGUS safety database and EudraVigilance and/or XEVMPD user certification would be a plus.

What we offer:

We offer a friendly and supportive culture that puts people first. We provide a competitive compensation and benefits package including 6% pension contribution, private medical insurance, sick pay and income protection insurance, life assurance and eyecare voucher scheme.

This job does not offer company sponsorship

Theradex is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment.

Job Type
Full Time
74 days ago

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