Apogee Therapeutics

Biotechnology

MedicalDirector,Pharmacovigilance

₹120–180L ~AI est. Remote Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Director candidates.

The Brief

“Medical Director, Pharmacovigilance at Apogee Therapeutics. Skills: Pharmacovigilance, Drug safety, Regulatory affairs. Identify emerging safety signals. Ensure appropriate escalation”

Industry & Context.

Biotechnology
Eligibility Requirements

Up to 20% travel, Mandatory in person attendance

What They're Looking For.

Must Have

MD degree required, 8 years pharmacovigilance experience, Global regulatory requirements expertise

Nice to Have

Exposure to biologics, I&I conditions experience, Dermatology indications experience, Respiratory indications experience, Late-stage development experience, Submissions experience

What You'll Do.

Identify emerging safety signals

Ensure appropriate escalation

Contribute to pharmacovigilance strategies

Maintain benefit-risk assessments

Collaborate with Regulatory Affairs

Develop responses to inquiries

Ensure high-quality MedDRA coding

Ensure appropriate event characterization

Ensure robust safety narratives

Lead preparation of DSURs

Lead preparation of IBs

Lead preparation of safety sections

Lead review of safety sections

Provide safety input to submissions

Provide safety input to protocol amendments

Provide safety input to health authority inquiries

Partner with Regulatory Affairs

Partner with Quality teams

Address safety findings

Address corrective actions

Collaborate with Clinical Development

Collaborate with Regulatory Affairs

Collaborate with Medical Affairs

Collaborate with Biostatistics

Collaborate with Data Management

Collaborate with Medical Writing

Support development of ISS

Support safety components of NDAs

Support safety components of BLAs

Support safety components of MAAs

Review safety content of publications

Review safety content of posters

Review safety content of abstracts

Review safety content of manuscripts

How You'll Work.

Team & Collaboration

Regulatory Affairs; Quality teams; Clinical Development; Medical Affairs; Biostatistics; Data Management; Medical Writing

Full Job Description

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R. E. values: Caring, Original, Resilient and Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! Role Summary We are seeking a Medical Director, Pharmacovigilance to join the Apogee Clinical Development team. In this newly created position, you will be responsible for safety aspects across Apogee’s pipeline. This role is critical in supporting regulatory approvals, patient safety, and long-term safety input into life-cycle management. Additionally, you will play a key role in supporting drug safety and pharmacovigilance activities

Free ATS check

Applying for this Medical Director, Pharmacovigilance role?

Most applicants get filtered before a human reads their resume. See if yours makes the cut.

How to Apply on Greenhouse

  • Create a Greenhouse profile before applying — it saves time across multiple applications.
  • Upload your resume as a PDF; the parser handles it better than Word.
  • Answer all knockout questions carefully — wrong answers auto-reject before a human sees you.
  • Enable email notifications to track application status in real time.

ANONYMOUS · UNFILTERED

What do employees actually say about Apogee Therapeutics?

Real rants from real employees. Read before you apply.

Read Company Rants →