Pharmacovigilance Operations Manager
As our Pharmacovigilance Operations Manager, you will manager the medical Pharmacovigilance operations and team for Athenex products and supports clinical development teams through all aspects of drug safety, regulatory submission processes and post market products.
Essential Job Functions/Responsibilities
- Manage pharmacovigilance operations for pre- and post-market products
- Direct management of safety physician(s) to support clinical study teams during all phases of execution of clinical research studies, from protocol development through final report
- Classify case information for appropriate distribution to internal and external business partners.
- Performs or oversees final quality review of cases; assures appropriate review of all SUSAR SAE cases for regulatory reporting purposes.
- Initiates new safety projects, including overseeing the development of study specific safety management plans, reconciliation plans and other study related documents.
- Review adverse event information received for completeness and consistency, initiate case follow-up activities/Adverse Event query management and may generate narratives or perform medical review in accordance with department processes.
- Act as liaison with CROs, internal departments and external business partners on Drug safety and pharmacovigilance operation management issues and clinical study related activities and ensure compliance with contracts and agreements.
- Ensures the uniform and timely processing of safety reports in accordance with SOPs, worldwide regulatory authority, and ethics committee expectations.
- Act as a PV/Drug safety Subject Matter Expert on cross-functional clinical studies and program teams for assigned products and provide expert guidance regarding new safety findings and trends. Conducts and participates in the evaluation of safety signal detection activities, monitoring, evaluation, interpretation and appropriate communication of safety information
- Reviews and assists with safety related activities associated with new drug applications / regulatory filings, benefit risk assessment and safety risk management and support activities related to risk minimization
- Oversee and review aggregate safety review documents (such as DSUR, PSUR, and other global periodic submissions) and participate in the development of safety sections of relevant clinical documents (e.g. protocols, Investigator brochures, informed consent forms, clinical study reports, responses to health authorities) on behalf of PV department.
- Supports preparation for regulatory audits/ inspection with evaluation of current processes and assesses alignment with regulatory expectations, guidelines, and mandates
- Review and approve the queries created by safety physicians to be sent to the investigator.
- Management of an industry standard PV database and associated SOPs/Work Instructions and business processes.
- Assist with creating policies, SOPs, forms and templates for efficient processing of ICSRs and aggregate reports.
- May perform other duties as assigned.
Required Education & Experience
- Doctor of Medicine (M.D.), Osteopathy (D.O.), foreign medical degree accepted
- Minimum of 7 years of product safety experience in pharmaceutical, biotech or clinical research organization, preferably oncology based.
- Minimum of 2 years leading or supervising a Pharmacovigilance or Pharmacovigilance Operations team
- Working knowledge of Oracle’s Argus Safety Suite or comparable database.
- Knowledge of GCP, ICH, GVP MedDRA, and Global regulations and requirements.
- Experienced in safety reviews of AEs/SAEs, IBs, protocols, clinical study reports, informed consents, and other safety-related documents.
- Skilled in preparation of DSUR and PSUR//PBRER according to US and international requirements
Required Skills & Abilities:
- Experienced in the evaluation and interpretation of data
- Strong motivational and leadership skills, promoting a team-based approach
- Strong interpersonal and communication skills, both verbal and written
- Solid judgment and decision-making skills with good attention to detail.
- Demonstrate flexibility within a dynamic, fast-paced, cross-functional team.
- Well organized and able to perform under stringent timelines.
- Experience with computer application including Microsoft Office, Outlook, etc.
- This position is remote but may include occasional travel for business needs.
- Computer work for long periods of time
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.