Vice President, Immunology, Medical Safety Evaluation
Our client is a pharmaceutical company. They have asked us to assist them in a search for a Vice President, Immunology, Medical Safety Evaluation.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Provides critical oversight of Product Safety Team Leads and other colleagues within Medical Safety Evaluation to set safety strategy across all developmental and marketed compounds in designated therapeutic area.
- Defines the safety strategy for the company products in the assigned therapeutic area. Drives the introduction of new or improved products to the portfolio.
- Provides strategic input for and review of the safety documents for the assigned Therapeutic Area.
- Interacts with and influences other cross functional departments to ensure the successful development, design, and implementation of comprehensive safety assessment for both developmental and marketed products for allocated Therapeutic Area.
- Communicates major safety issues to various cross-functional teams in collaboration with the Product Safety Team Leads.
- Communicates important product medical safety issues in the assigned Therapeutic Area to the corporate safety governance bodies, such as Safety Review Board and Safety Council.
- Serves as voting member at Safety Review Board (SRB) and is recognized as senior leader for drug safety at the company.
- Is an expert on safety statistics and strategic liaison with the Safety Statistics Organization to develop statistical analysis plan for all therapeutic areas.
- Leads implementation of Safety Assessment Committee and provide direction for implementation of SAC in all therapeutic areas as necessary.
- Provides the medical safety interpretation of company products in the assigned Therapeutic Area to outside organizations, such as national regulatory and health authorities.
- Provides medical safety and pharmacovigilance strategy and interpretation to the leadership team of Pharmacovigilance and Patient Safety (PPS).
- Drives and advances medical safety capability and capacity both strategically and with innovative approaches.
- Manages the team of several levels of Medical Directors (TA Heads, Executive Medical Directors, Group Medical Directors, Medical Directors, Associate Medical Directors). Is responsible for hiring, onboarding, mentoring, training, and supporting career development of these individuals.
- Coaches and mentors medical safety evaluation staff.
- Acts as a safety science leader and key opinion leader internally and externally.
- Develops a network across company leaders. Actively supports open exchange of expert medical opinions and visions of technology and data analytics.
- A Medical degree with relevant therapeutics specialty in an academic or hospital environment is required.
- Completion of a residency program with direct patient management and care is strongly preferred.
- Completion of a subspecialty fellowship is desirable.
- A minimum of 10 years of experience in either clinical trial/development in the pharmaceutical industry or in pharmacovigilance is required.
- Must have a minimum of five years of senior leadership experience.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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