Director, Medical Safety Physician Product Lead (m/f/d)
Otsuka Pharma GmbH
Director, Medical Safety Physician Product Lead (m/f/d) at Otsuka Pharma GmbH is a full time role based in Remote · Homeoffice (remote). Listed skills: Global Pharmacovigilance and Remote. It was published on 6 August 2026 and was open at last check.
| Role | Director, Medical Safety Physician Product Lead (m/f/d) |
|---|---|
| Company | Otsuka Pharma GmbH |
| Location | Remote · Homeoffice (remote) |
| Employment type | Full Time |
| Skills listed | Global Pharmacovigilance and Remote |
| Published | 6 August 2026 |
| Status | Open at last check |
As Medical Safety Physician Product Lead (Director), you will play a key role in ensuring the safety of our products across their entire lifecycle. You will combine medical expertise with strategic leadership to drive global pharmacovigilance activities, collaborate with cross-functional teams, and shape robust safety and risk management strategies. This position offers broad exposure to international stakeholders and the opportunity to directly contribute to patient safety and regulatory excellence.
- Lead medical safety strategy for assigned products across the full lifecycle (Phase 1–4)
- Have special focus on Early Development programs and regulatory filing experience, ensuring robust safety strategies are integrated from first-in-human studies through proof-of-concept and supporting timely, high-quality safety deliverables for global submissions (IND, NDA, MAA)
- Oversee safety profile, benefit-risk evaluation, and signal detection activities
- Drive and chair Safety Management Team (SMT) meetings
- Ensure execution of global pharmacovigilance (PV) activities and governance processes
- Provide safety leadership in cross-functional global teams (e.g. Regulatory, Clinical, Quality)
- Act as key contact for Health Authorities (e.g. EMA, FDA) on safety matters
- Lead preparation and review of safety documents (e.g. PSURs, DSURs, Risk Management Plans, SmPC)
- Ensure scientific accuracy and regulatory compliance of safety-related submissions
- Support global regulatory filings and safety-related responses (e.g. NDA, MAA)
- Contribute to clinical trial activities as PV representative
- Coach and support team members on safety strategy and deliverables
- Act as subject matter expert for audits, inspections, and process improvements
- Medical Doctor with clinical experience
- Multiple years of experience in pharmacovigilance / medical safety
- Strong knowledge of global PV regulations (EU GVP, FDA requirements)
- Experience with global development programs and regulatory submissions
- Solid understanding of benefit-risk evaluation and safety science
- Strong analytical thinking and structured working style
- Excellent communication skills and ability to work in international teams
- Fluency in English and willingness to travel / collaborate across time zones
Create your free OnJob profile to apply — we'll take you to Otsuka Pharma GmbH's application after sign-up. · Posted 6 Aug 2026.
Director, Medical Safety Physician Product Lead (m/f/d) at Otsuka Pharma GmbH — questions answered
What does the Director, Medical Safety Physician Product Lead (m/f/d) role at Otsuka Pharma GmbH pay?
Otsuka Pharma GmbH does not publish a salary on this Director, Medical Safety Physician Product Lead (m/f/d) listing, so OnJob shows no figure for it rather than an estimate. For what this role pays across the market, the OnJob salary guides aggregate the live listings that do disclose pay.
Is the Director, Medical Safety Physician Product Lead (m/f/d) role at Otsuka Pharma GmbH remote?
Yes — Otsuka Pharma GmbH advertises this Director, Medical Safety Physician Product Lead (m/f/d) role as remote, tied to Remote · Homeoffice, and it is listed as full time work. Remote terms come from the employer's own posting, so confirm the expected working hours, timezone and any on-site days with Otsuka Pharma GmbH before you apply.
What skills does the Director, Medical Safety Physician Product Lead (m/f/d) role at Otsuka Pharma GmbH require?
The Director, Medical Safety Physician Product Lead (m/f/d) at Otsuka Pharma GmbH listing names Global Pharmacovigilance and Remote. Those are the skills the employer put on the posting itself, so they are the ones worth matching in your profile and covering first in an interview.
Is the Director, Medical Safety Physician Product Lead (m/f/d) role at Otsuka Pharma GmbH still open?
The Director, Medical Safety Physician Product Lead (m/f/d) posting at Otsuka Pharma GmbH was open at OnJob's last check of the employer's careers page, having been published on 6 August 2026. OnJob re-checks source listings on each build and marks a role closed once it disappears, but listings can close without notice, so the employer's own page is the final word.
How do you apply for the Director, Medical Safety Physician Product Lead (m/f/d) role at Otsuka Pharma GmbH?
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