BlueRock Therapeutics
Senior Director, Pharmacovigilance
BlueRock Therapeutics, Cambridge, Massachusetts, us, 02140
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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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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