Pharmacovigilance Alliance/Agreement Consultant - REMOTE

Proclinical is seeking a remote Pharmacovigilance Alliance/Agreement Consultant for a leading biopharmaceutical company. This individual will be responsible for creating and/or updating existing PVAs. They will also author SOPs for the DSPV group in partnership with key stakeholders.

Must be eligible to work in the US.

Job Responsibility:

• Develop and maintain a Pharmacovigilance Agreement (PVA) template and SOP that is aligned with the business needs and includes the required legal components and regulatory requirements related to PV Agreements.
• Under DSPV teams' direction, collaborate with Legal in the preparation or revision of PVAs and ensure any/all Legal requirements are documented within the PVA.
• Work with the DSPV team and with PV partners to develop, finalize, and revise PVAs as needed.
• Collaborate with business owners and Legal to ensure contracts with external parties contain the appropriate Safety/PV language to ensure complete and timely reporting of safety information to DSPV.
• Maintain and update the PV language templates used for third party contracts.
• Monitor and maintain the DSPV PVA Tracking Tool.
• Develop and maintain policies and procedures for the DSPV Quality System and provide DSPV Quality Assurance support for SOPs, auditing, deviations, training, and CAPAs.
• Monitor adherence and compliance with department documented procedures.

Skills and Requirements:

• Bachelor's degree in life sciences, pharmacy, nursing, or equivalent health experience.
• 5+ years of experience in a Drug Safety/Pharmacovigilance role in the pharmaceutical/biotechnology industry, including global clinical trials and post-marketing.
• 5+ years of experience working on pharmacovigilance alliance/agreement plans.
• Advanced degree in life sciences preferred.
• Previous experience with writing or drafting Pharmacovigilance Agreements.
• Demonstrated ability to create, evaluate, and maintain effective business processes and implement procedures, systems, and tools to maximize resources within a Drug Safety department.
• Prior pharmaceutical or biotechnology drug development experience.
• Comprehensive knowledge of the US FDA regulations and the international pharmacovigilance regulations and requirements, including European Medicines Agency (EMA) Good Pharmacovigilance Practices (GPV).
• Excellent oral and written communication skills.
• Strong interpersonal and leadership skills and demonstrated ability to manage, motivate, and influence work behaviors of individuals who are not direct reports.
• Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.
• Must have excellent interpersonal skills, the ability to develop important relationships with key stakeholders, exceptional conflict management and negotiation skills, and the ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations.

If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at (+1) 617-830-1769 or b.forsen@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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