What are the responsibilities and job description for the Senior Director, Pharmacovigilance position at BlueRock Therapeutics?
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.
\n- 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)
- 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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