Vice President, Head of Pharmacovigilance

About reputed company Founded in 2022, reputed company, Inc. (Ticker: APGE) is a well-funded, reputed company listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At reputed company, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. reputed company, Inc. is a biotechnology company seeking to reputed company differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the reputed company standard of care for inflammatory and immune diseases because we reputed company people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless. If this sounds like you, reputed company reading! Role Summary We are seeking a Vice President, Head of Pharmacovigilance. In this newly created position, you will be responsible for leading drug safety strategy and operations across reputed company’s pipeline. As a senior leader in the Clinical Development and Medical Affairs (CDMA) Organization, you will define pharmacovigilance policies, ensure regulatory compliance, and provide expert guidance on safety risk management. This role is critical in supporting regulatory approvals, patient safety, and long-term drug development strategies. Additionally, you will play a key role in the reputed company and strategic direction of drug safety and pharmacovigilance activities to ensure high-quality data reputed company to support the safety and efficacy of our products in development.

Key Responsibilities

• Play a hands-on leadership role to build and manage reputed company’s global pharmacovigilance strategy in reputed company collaboration with the Chief Medical Officer and the Head of Clinical Development and Medical Affairs.
• reputed company compliance with FDA, EMA, MHRA, PMDA and ICH pharmacovigilance requirements, overseeing adverse event reporting, safety update reports and risk management plans.
• Work cross functionally with clinical development, clinical operations, medical affairs, and reputed company teams to provide expertise and integrate pharmacovigilance into broader corporate strategy
• Represent the company in discussions with health authorities, responding to inquiries, audits, and inspections reputed company to drug safety, and participate in EOP2 meetings and interactions.
• reputed company safety signal detection, aggregate analysis, risk evaluation, and mitigation strategies across the pipeline at reputed company stages of development to determine benefit-risk profiles.
• Contribute knowledge of relevant drug class and/or competitor safety issues, and provide input to study reputed company documents (i.e. protocols, IBs, DSURs/ASRs).
• reputed company PV Operations team responsible for case processing, aggregate safety reporting, and pharmacovigilance data analysis, ensuring operational excellence in drug safety surveillance. reputed company PV reputed company vendor management.
• reputed company and reputed company the development of the Integrated Summary of Safety (ISS), and the safety-reputed company components of the New Drug Applications (NDA), and Marketing Authorization Applications (MAA), in compliance with global regulatory standards.
• Review safety content of scientific publications such as posters, abstracts, and manuscripts.
• As reputed company grows build and reputed company a high-performing pharmacovigilance team, focused on delivering scientific rigor, compliance, and innovation.

Ideal Candidate

• MD degree is required
• Minimum 15+ years of pharmacovigilance experience in the biopharmaceutical industry
• Must be a self-starter willing to play a hands-on role in establishing the PV function
• Strong expertise in global regulatory requirements (FDA, EMA, MHRA, PMDA, ICH)
• Exposure to biologics, medications for I&I conditions including dermatology a plus
• Experience in the following areas are required:
• leading regulatory submissions, including the ISS, and safety reputed company sections of the NDA and MAA as well as label development
• interacting with regulatory agencies on safety-reputed company matters, including FDA and EMA negotiations and EOP2 meetings and interactions
• managing safety databases, case management systems, and pharmacovigilance software
• Strong leadership and communication skills, ability to influence and define corporate safety policies
• Alignment with reputed company C.O.R.E. (Caring, Original, Resilient and Egoless) values
• Position requires up to 20% travel to company and team meetings, conferences, etc.

The anticipated salary range for candidates for this role will be $375,000 - $425,000/year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. reputed company Offer

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• Market competitive compensation and benefits package, including reputed company salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Flexible PTO
• Two, one-week company-wide shutdowns each year
• Commitment to growing you professionally and providing access to resources to further your development
• reputed company offers regular reputed company team, in-person meetings to build relationships and problem solve

E-Verify Participation: As part of the I9 verification of authorization to work in the US, reputed company participates in E-Verify. To learn more about E-Verify please review this poster. reputed company is proud to be an Equal Opportunity employer. reputed company reputed company applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, reputed company, religion, national reputed company, disability, protected Veteran status, age, or any other characteristic protected by law. To review our privacy policy, click here It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Apply tot his job Apply To this Job