Director, Pharmacovigilance Operations at Radius Health in Wayne, PA

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Description


Radius Health

Radius Health is an equal opportunity employer. EEO/Disabled Individuals/Veterans. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HRconnect@radiuspharm.com. Click here to navigate to the “EEO is the Law” poster. Click here to navigate Radius Health’s Pay Transparency Policy.

US-PA-Wayne

Job ID 2019-1970
# of Openings 1
Category Pharmacovigilance - Dept

Overview

The incumbent provides oversight for the PV Operations elements of the pharmacovigilance function. This includes Vendor oversight; Training; Business integration; Quality Management System (QMS); Safety Data Exchange Agreements (SDEAs); PV Safety database; and Budgets.

He/she also leads, and actively contributes to, the development or revision of existing PV processes related, but which may not be limited to: Quality, standards, and training.

The incumbent works cross-functionally with internal departments/key stakeholders and external resources on pharmacovigilance-related matters.

Responsibilities

  • Provides oversight for work performed by pharmacovigilance vendor(s).
  • Participates in process improvement and vendor-client Safety Management Plans and timelines for processing and reporting safety data from clinical trials and post-marketing surveillance.
  • Accountable for business integration including safety data migration and integrating new assets or companies into Radius PV system.
  • Accountable for development or revision of SOPs, work instructions, guidance in regards to all functions within PV.
  • Participates in investigator meetings as needed to train investigators and qualified site personnel in the collection and reporting of SAEs to study sponsor; receives clinical study SAE reports, reviews for medical/regulatory content and assures accuracy per protocol requirements; interfaces with medical monitors for medical assessment and regulatory classification of SAEs; manages and facilitates SAE reconciliation across projects to ensure compliance with objectives and goals, adverse event follow-up and case closure.
  • Accountable for Quality Management System within PV including compliance, best practices, and continuous process improvements.
  • Accountable for working with relevant internal departments, and actively contributing to, the development of the PSMF.
  • Works closely and collaborates with EU and local Qualified Person (QP) to develop new or maintain pharmacovigilance processes supporting both development and marketed/commercial products.
  • Develops SDEAs or pharmacovigilance agreement with Radius partners and vendors for specific obligations for safety data exchange and reporting.
  • Builds relationships, and collaborates with, Clinical Development to improve process for safety reporting, reconciliation of safety data and protocol template development.
  • Builds relationships, and collaborates with, Regulatory Affairs Operations to improve process for safety reporting to global Health Authorities (HA).
  • Contributes to inspection readiness and leads HA inspections of Radius's pharmacovigilance function.
  • Responsible for PV budgets, MSA and SOW with PV vendors.
  • Performs other tasks and assignments as needed and specified by management.


Work Environment:

The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.

Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.

Qualifications

  • BSN/RN, Bachelor's degree in Pharmacy or PharmD degree and a minimum of 10 years progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology or related environment, at least 3 of which were spent in a leadership role within pharmacovigilance.
  • Expert knowledge of relevant Food and Drug Administration (FDA), European Union (EU) and International Conference on Harmonisation (ICH) guidelines, initiatives, and regulations governing pharmacovigilance.
  • Experience leading and contributing to process improvements, quality management system, inspection readiness, Health Authority audits, standardization of safety reports, SDEA negotiations, vendor management, etc.
  • Extensive working knowledge of medical terminology and Medical Dictionary of Regulatory Activities (MedDRA).
  • Demonstrated hands-on experience identifying, developing and implementing improvements to departmental processes that increase efficiency and maintain or improve quality.
  • Proficiency with Microsoft Office and 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.

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