- Strategic Leadership: Articulate and execute the strategic vision for the pharmacovigilance department, aligning with the organization's objectives and the evolving regulatory environment. Champion excellence in drug safety and pharmacovigilance practices throughout the company.
- Regulatory Compliance and Oversight: Oversee adherence to both national and international pharmacovigilance regulations and guidelines. Lead the establishment and refinement of SOPs, ensuring all pharmacovigilance activities meet the highest standards.
- Risk Management: Direct the identification, evaluation, mitigation, and reporting of risks related to product safety. Innovate and implement strategies to enhance patient safety and product risk management.
- Global Safety Surveillance: Ensure the development and execution of comprehensive safety surveillance programs. Offer strategic guidance for the monitoring, detection, assessment, mitigation, and reporting of adverse events and other safety information.
- Cross-
- Advanced degree (MD, PharmD, PhD) in a relevant scientific discipline.
- Extensive experience (10+ years) in drug safety and pharmacovigilance within the biotech or pharmaceutical industry, including significant leadership experience.
- Thorough knowledge of global pharmacovigilance regulations and guidelines.
- Proven track record of strategic planning and execution in pharmacovigilance.
- Strong leadership and team management skills.
- Excellent communication, negotiation, and interpersonal skills.
- Ability to work effectively in a fast-paced and dynamic environment.
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Executive Director, Drug Safety and Pharmacovigilance - Waltham, United States - Morphic Holding, Inc.
Description
About Morphic Therapeutic
Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer.
In collaboration with Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company's unique understanding of integrin structure and biology.
For more information, visitMorphic is advancing fully-owned oral integrin therapeutic candidates with the initial clinical trials beginning in 2020.
Our immediate focus is on the areas where the clinical activity of antibody inhibitors of integrins is precedented, thus enabling a rapid path to clinical proof-of-concept.
Morphic Therapeutic is located in the BioHub in Waltham, MA.We are seeking a highly talented and motivated individual to join our culture of teamwork, craftsmanship, tenacity, compassion, integrity, and beauty.
Job Description:
Reporting directly to the Chief Medical Officer, the Executive Director of Pharmacovigilance occupies a pivotal leadership role within Morphic Therapeutic.
This position is tasked with setting the strategic direction and ensuring the operational effectiveness of the Drug Safety and Pharmacovigilance group.
The role demands avisionary leader with profound expertise in pharmacovigilance, regulatory compliance, and risk management strategies.The Executive Director will guarantee that our product development and surveillance initiatives are conducted with paramount standards of patient safety, adhering to the rigorous demands of global regulatory authorities.
Essential Job Functions:
Functional Leadership:
Act as the principal pharmacovigilance contact for other departments, regulatory agencies, and external partners. Promote an integrated approach to drug safety within the organization.
Qualifications:
Required
Cultural Fit:
Our culture is collaborative, one where people enjoy coming to work. We are a small,
entrepreneurial company where everyone pitches in and works together to do whatever
it takes to get things done. Our team is passionate, enthusiastic, and committed.
We have a fast-paced, high accountability environment. We have a flat organization, and
our leaders lead through influence and interpersonal skills, not command and control.
Everyone on the team, including our CEO, is an individual contributor.
We seek an individual for this position who shares our values and our enthusiasm about
bringing new medicines to the patients and families that need them. We seek someone
who will enjoy working in a small company environment and be motivated by the
opportunity to directly influence and help shape the future direction and culture of our
company.
Morphic Therapeutic is an equal opportunity employer committed to providing an environment that maximizes our employees' development and achievement goals.
We strive to treat each employee as an individual, as we seek to foster a spirit of teamwork to help change patients' lives.
In addition to a competitive compensation and benefits package that includes medical, dental and vision coverage, a 401K and a generous vacation and holiday schedule.
