Head, Global Safety & Pharmacovigilance
Our client is a global pharmaceutical company. They have asked us to assist them in their search for a Head, Global Safety & Pharmacovigilance.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Manages and leads the Safety and Pharmacovigilance department.
- Provides direction and leadership regarding safety vendors selection and management. Is accountable for effective oversight of outsourced operational activities, measuring vendor performance, and contracted Service Level Agreements(s).
- Oversees the appropriate management of safety data exchange agreements, safety management plans,
and other operating procedures with business partners as required.
- Collaborates with team members on the development and implementation of safety and pharmacovigilance procedures and documents used to provide training across the establishment.
- Ensures compliance, inspection readiness, and preparedness for regulatory agencies inspection activities related to safety. Supports interactions and reports, responds, and resolves safety questions from the FDA, EMEA, and other regulatory authorities, and responds to regulatory agency audits.
- Identifies opportunities for process efficiencies and participates in process improvement initiatives.
- Ensures compliance with health authority regulations in all aspects of case processing and reporting.
- Executes EU Pharmacovigilance requirements including QPPV oversight.
- Works with regulatory affairs to maintain and update regulatory reporting rules.
- Tracks compliance of expedited safety reports.
- Manages signal detection and safety reporting activities in partnership with external vendors.
- Manages aggregate report production and ensures compliance with timely reporting and serves as content owner of relevant sections of pharmacovigilance related documents.
- Leads Safety Review Meetings for company product(s). Provides strategic or operational input on project teams and interacts with senior management to report project updates.
- Collaborates with pre-clinical and clinical development to better assess and understand drug safety profiles. Develops responses to health authorities regarding safety and pharmacovigilance.
- Oversees Safety Operations and reporting during clinical trials.
- Partners with clinical operations, regulatory affairs, clinical research organizations (CRO) and data management groups regarding safety data collection and data reconciliation for all clinical trials. Serves as point of contact for Safety risks identified by Medical Monitor. Provides medical/clinical review of applicable Case Safety reports. Oversees the resolution of safety queries.
- Contributes to Investigator’s Brochure and provides standardized safety language where required.
- Plans and implements database safety reconciliations in collaboration with data management, compliance and CROs as required.
- A Medical degree or PharmD degree is preferred. Board certification and/or experience in neurology indication(s) is a plus.
- A minimum of 15 years of safety experience in pre- and post- marketing environments is required.
- Excellent leadership qualities such as strategic thinking, people, and resource management expertise are required.
- Must have a working knowledge of US and EU regulations, ICH guidelines, and common drug safety databases.
- Effective project management skills with a demonstrated ability to provide critical and timely insight, and analytical problem-solving skills with a broad perspective are required.
- Must have the ability to communicate complex clinical issues in a scientifically sound and understandable way.
- Experience working with all levels of management and consulting with key functions to influence greater outcomes is required.
- Must be skilled at negotiating with business partners and management and influencing senior level
leaders regarding matters of significance to the department or, more broadly, the organization.
- Must be adept at creating and communicating a clear vision among team members effectively aligning
resources to achieve goals.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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