Pharmacovigilance Medical Director

Job Description

Wayne, PA 6m ++ contract

  Under the oversight of the PVRM TA Head, the PVRM Medical Lead is responsible for ensuring development and execution of risk management strategies, appropriate medical safety assessments and surveillance, compliant regulatory authority reporting, and communication of safety information for assigned Global products.

Responsibilities

  • Oversee investigational and postmarketing regulatory reporting and pharmacovigilance activities for assigned Global products

  • Lead the development and execution of risk management strategies and author internal risk tracking plans and risk management/pharmacovigilance plans for submission to global health authorities for assigned products

  • Medically review individual case safety reports from all sources for assigned products.

  • Oversee, prepare, and review Periodic/Annual Reports (FDA) and Periodic Safety Update Reports and other Benefit/Risk Update Reports (FDA and Global Regulatory Authorities)

  • Oversee, prepare, and review responses to ad hoc regulatory queries, and signaling topic reports

  • Assist the VP in developing and maintaining state-of-the-art pharmacovigilance processes and procedures within Shire R&D, and as part of the Global PV & RM organization.

• Lead pharmacovigilance activities as a member of drug development project teams; co-lead Safety Review Teams

• Lead safety-labeling activities for assigned products

• Support the Qualified Person for Pharmacovigilance in the EEA relative to issues related to assigned products 

Qualifications

Education and Experience Requirements

• MD required.

• Postgraduate training in a sub-specialty preferred, hands-on clinical practice experience desirable

• Generally has at least 8 years of pharmaceutical industry experience, with a minimum of 5 years of pharmacovigilance experience.

Key Skills, Abilities, and Competencies

• Strong post-marketing and investigational individual case and aggregate assessment/review/ documentation skills; must have experience in writing/oversight of Annual Reports, PSURs

• Must have a strong working knowledge of ICH guidelines and global regulations, and must be experienced in safety reviews of IBs, protocols, final clinical study reports, and summaries of safety.

• Experience in communicating with the EMEA and/or FDA or other recognized local Competent Authorities.

• Global pharmacovigilance experience.

• Ability to read, analyze and interpret scientific and technical journals.

• Must have very strong English language writing skills and mature verbal communications and presentation skills.

  • Working knowledge of MedDRA coding and case series retrieval strategies.

• Experience using a large-scale electronic data storage and retrieval system.

• Requires strong attention to detail in composing and/or proofing materials, establishing priorities, scheduling and meeting deadlines

• Ability to work in a fast paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands.

• Ability to work independently, take initiative and complete tasks to deadlines.

• Proven ability to independently resolve problems and conflicts.

• Excellent interpersonal, communication, analytical, managerial, and organizational skills.

• Demonstrated ability to motivate, mentor, influence, and collaborate with others in a complex global organizational matrix.

• Ability to empathize and support staff working in other national environments

Additional Information