Pharmacovigilance Team Supervisor
1 month ago
About Allergan: Allergan is dedicated to discovering and delivering innovative medicines and solutions that address significant health challenges today and in the future.
Our commitment is to make a meaningful impact on individuals' lives across several critical therapeutic areas, including immunology, oncology, neuroscience, and eye care, alongside our offerings in the Allergan Aesthetics portfolio.
Key Responsibilities:
- Contribute valuable insights to strategic safety discussions to ensure the success of both development products and market benefit/risk evaluations.
- Utilize in-depth knowledge of local regulations to guide the strategic direction for pharmacovigilance and regulatory inquiries.
- Provide expertise in the creation of safety deliverables and participate in local Health Authority review boards or meetings as necessary.
- Translate affiliate product safety information needs to the Pharmacovigilance Safety Science experts, ensuring a closed loop on information requirements.
- Anticipate and identify product safety information that is critical to development assets.
- Enhance the understanding of benefit-risk positions and critical insights among affiliate medical teams, particularly regarding safety topics discussed with regulatory agencies.
- Ensure preparedness for implementing post-marketing safety commitments.
- Facilitate timely connections between Safety Science experts and affiliate teams to maximize the success of development programs and regulatory submissions.
- Collaborate with cross-functional teams to gather insights on regulatory and commercial strategies for development and late-stage assets, providing pharmacovigilance and clinical safety expertise.
- Evaluate the impact of these strategies on risk management planning and pharmacovigilance deliverables.
- Present product safety information at key affiliate, regional, and global leadership meetings, offering appropriate local context to inform business decisions.
- Share local safety insights with Pharmacovigilance Safety Science leaders to ensure alignment with Global Pharmacovigilance strategies.
- Promote best practice sharing across Area Pharmacovigilance Product Leads and the broader International Pharmacovigilance and Safety Science organization.
Qualifications:
A Bachelor's degree in a healthcare discipline (e.g., Life Sciences, Pharmacy, Nursing, or Biomedical fields) is required, with a Master's or advanced degree preferred.
At least 7 years of experience in the healthcare sector, with a robust understanding of drug development and licensing processes, is essential.
Extensive experience in Pharmacovigilance and Medical Safety is mandatory, with a comprehensive understanding of Pharmacovigilance activities and deliverables throughout the product lifecycle.
The ability to interpret a product's safety profile and contextualize it within local medical frameworks to preemptively address potential safety concerns is crucial.
A strong grasp of the interplay between regulations and scientific principles for drug safety is required.
Proven communication skills to effectively convey and synthesize relevant information to senior executives are essential.
Allergan is an equal opportunity employer committed to integrity, innovation, and diversity. We value qualified individuals without discrimination based on race, color, religion, national origin, age, sex, disability, or any other legally protected status.
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