Senior Director, Pharmacovigilance

The Senior Director, Pharmacovigilance will report to the Vice President, Head of Global Safety & Pharmacovigilance and will be responsible for supporting the Development organization as a PV expert and providing strategic and operational PV support for Blue Rock’s developmental products in close collaboration with cross-functional colleagues.

Responsibilities:

• Serves as safety lead for assigned product
• Provides independent oversight of daily safety monitoring activities and safety operations of clinical trials for the assigned product
• Leads the signal management process for assigned products including the implementation of the signal detection strategy and facilitated cross-functional safety management team meetings
• Provides PV subject matter expertise on cross-functional teams
• Leads cross-functional Safety Management Team meetings; includes coordinating materials, presenting data, preparing meeting minutes and action items.
• Reviews and provides PV input for development of protocols, IBs, ICFs, SAPs, CSRs and other relevant study documents
• Participates in writing of aggregate safety reports, e.g., DSURs
• Provides subject matter expertise and input for regulatory submissions and regulatory responses, collaborating with cross-functional areas as appropriate
• Oversees PV CRO(s)

Minimum Requirements:

• Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in PV
• Minimum 8 years’ pharmaceutical industry experience, including a minimum of 5 years’ experience in PV
• Knowledge of MedDRA terminology and its application
• Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data
• Experience in the preparation and authoring of pre- and post- aggregate safety reports
• Thorough understanding of the drug development process and context applicable to safety surveillance activities
• Ability to execute and follow-through to completion and documentation
• Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
• Independently motivated, detail oriented and good problem solving ability
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
• Excellent communication skills and ability to influence across multiple functions.

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