Senior Pharmacovigilance Safety Manager
1 month ago
At Allergan, our commitment is to discover and deliver groundbreaking therapies that address significant health challenges today while preparing for the medical needs of tomorrow. We aim to create a profound impact on the lives of individuals across various therapeutic domains, including immunology, oncology, neuroscience, and eye care, along with our offerings in the Allergan Aesthetics portfolio. For further insights about Allergan, please visit our website.
Role Overview- Contribute valuable insights to critical strategic safety discussions to ensure the successful development of products and ongoing market benefit/risk evaluations.
- Utilize knowledge of local regulations to provide strategic guidance for pharmacovigilance submissions, approvals, and regulatory inquiries.
- Provide expertise as required for the development of safety documentation and participate in local Health Authority review boards/meetings when necessary.
- Assess and communicate affiliate product safety information requirements to the Pharmacovigilance Safety Science experts, ensuring a comprehensive response to information needs. Anticipate essential product safety information relevant to development projects.
- Enhance the understanding of benefit-risk positions and critical insights among Affiliate medical teams (e.g., safety discussions with regulatory bodies, post-marketing safety research). Ensure preparedness for executing post-marketing safety obligations.
- Foster timely connections between Safety Science experts and Affiliate teams collaborating with Pharmacovigilance to optimize the success of development initiatives and regulatory submissions.
- Collaborate with affiliate and area cross-functional teams to proactively gather insights on regulatory and commercial strategies for development and late-stage assets, providing pharmacovigilance and clinical safety expertise. Assess the implications of these strategies on risk management planning and pharmacovigilance deliverables/activities. Engage with Pharmacovigilance and affiliate teams to share pertinent information and ensure readiness to support strategies.
- Present product safety data at key affiliate, regional, and global leadership meetings, providing relevant local context to guide local business decisions and activities.
- Share local safety insights with Pharmacovigilance Safety Science leaders to ensure these are integrated into Global Pharmacovigilance strategies.
- Promote best practice sharing among Area Pharmacovigilance Product Leads and more broadly across the International Pharmacovigilance and Safety Science organization.
Required Education:
A Bachelor's degree in a healthcare-related field (e.g., Life Sciences, Pharmacy, Nursing, or Biomedical disciplines); a Master's or advanced degree is preferred.
Required Experience:
- A minimum of 7 years of experience in the healthcare sector with a robust understanding of the drug development and licensing processes.
- Extensive experience in Pharmacovigilance and Medical Safety is essential (e.g., Medical Safety Physician). Comprehensive knowledge of pharmacovigilance and medical safety activities and deliverables throughout the product lifecycle is required to maintain the product's benefit-risk profile.
- Ability to comprehend the safety profile of products and contextualize this within local medical frameworks to anticipate and address potential safety concerns.
- Understanding of the interplay between regulations and scientific principles to enhance drug safety.
- Strong leadership presence coupled with excellent communication and presentation skills.
- Proven capability to effectively convey and synthesize relevant information clearly and impactfully to senior leadership.
- Ability to quickly connect strategies and decisions; adept at asking insightful questions and proactively anticipating information necessary for informed business decisions.
- Capacity to collaborate effectively with colleagues across organizational boundaries; skilled in rapidly establishing trusted relationships within affiliates, at regional/area levels, and across therapeutic areas.
- High level of strategic thinking and demonstrated problem-solving abilities; resourceful and proactive in accessing information; capable of thinking on one's feet.
Allergan is an equal opportunity employer committed to integrity, innovation, transformation, community service, and embracing diversity and inclusion. Our policy is to employ qualified individuals of the highest ability without discrimination against any employee or applicant based on race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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