Director Pharmacovigilance Risk Management

Proclinical is currently recruiting for a Director Pharmacovigilance Risk Management with a leading biotechnology company located remotely. As the PV Risk Management Director, you will be responsible for developing and implementing infrastructure to support global pre/post-marketing risk management activities, including rare signal detection methodology across vaccine platforms.

Job Responsibilities:

• Develop and implement infrastructure to support global post-marketing pharmacovigilance activities.
• Develop and implement infrastructure to support pre- and post-marketing safety surveillance, signal detection, benefit-risk evaluations, and risk management activities.
• Contribute in the evaluation of safety and supporting documents and responses to regulatory authorities.
• Collaborate with Clinical Development and/or Contract Research Organization (CRO) Medical Monitor to ensure that information is available to allow for informed medical review and benefit-risk assessment.
• Collaborate with Product Safety team members to ensure appropriate and timely communication/dissemination of safety information.
• Represent Product Safety/Pharmacovigilance on cross-functional product/project team as required. * Represent Pharmacovigilance for regulatory inspections and audits and contribute to developing correction action plans when needed.

Skills and Requirements:

• Health Care Professional (HCP) or Master's Degree in scientific related field.
• Minimum of 15 years leadership pharmacovigilance experience in support of phase 1 to phase 3 global clinical trials as well as post-marketing.
• Expertise in clinical safety assessment, safety signal detection and risk management.
• Expert in global clinical and post-marketing safety regulations including FDA, ICH Guidelines, and EU.
• Experience building PV capabilities, both internally and externally with a range of partners is desired.
• Consistently demonstrates leadership qualities; i.e., effectively communicates cross-functionally, remains flexible and leads team members and cross-functional partners when change is encountered or necessary, maintains accountability to ensure deliverables/timelines are met, produces high-quality work on complex problems, and performs team-assigned work on time and effectively. Frequently mentors more junior team members and peers and builds and maintains networks with key contacts.

If you are having difficulty in applying or if you have any questions, please contact Nicole Aganon at (+1) 347-293-1161 or n.aganon@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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