SENIOR DIRECTOR, PHARMACOVIGILANCE
Location: Remote/Hybrid (U.S.-based/East Coast Preferred, with occasional travel)
Reports to: EVP Medical, Clinical & Regulatory Affairs
COMPANY OVERVIEW
Outlook Therapeutics, Inc. is a biopharmaceutical company dedicated to redefining the standard of care in retinal diseases. Our anti-VEGF ophthalmic biological product for wet AMD and related conditions operates in a launch environment across priority regions. With commercial launches advancing globally, we are expanding our leadership team to strengthen our corporate strategy and business development capabilities.
ROLE SUMMARY
The Senior Director, Pharmacovigilance will lead global pharmacovigilance work for Outlook Therapeutics. You will guide safety strategy, oversee safety operations, and ensure compliance with global regulations. You will lead adverse event reporting, literature screening, signal detection, aggregate report development, inspection readiness, and risk management. You will work across clinical development, regulatory affairs, and commercial teams. You will work in a small company setting where decisions move quickly and leaders stay close to the science and the field.
POSITION RESPONSIBILITIES
- Develop and implement a long term vision for pharmacovigilance aligned with company goals.
- Track global regulatory requirements and emerging trends to anticipate needs.
- Lead cross functional work between pharmacovigilance, clinical development, regulatory affairs, and commercial teams.
- Develop and maintain policies and procedures that meet FDA, EMA, ICH, and other global requirements.
- Oversee vendors managing case processing, literature screening, signal detection, aggregate reports, and risk management.
- Monitor compliance with global reporting requirements.
- Oversee signal management activities and aggregate report development such as PSUR, DSUR, PBRER, and PADER.
- Support inspection readiness and take part in inspections and audits.
- Establish pharmacovigilance agreements and safety data exchange agreements with partners.
- Monitor vendor performance through KPIs, metrics, and oversight reports.
- Maintain strong knowledge of global pharmacovigilance regulations to guide internal processes.
CANDIDATE QUALIFICATIONS
- Advanced degree in pharmacy, medicine, life sciences, or a related field.
- Ten or more years of pharmaceutical industry experience.
- Eight or more years of experience in pharmacovigilance.
- Experience working with global partners and vendors.
- Strong understanding of global pharmacovigilance regulations across FDA, EMA, MHRA, and ICH.
- Background in developing and implementing pharmacovigilance strategy and policies.
- Strong communication skills and the ability to work across functions.
- Experience with regulatory inspections and interactions.
- Experience overseeing safety vendors and managing performance.
TRAVEL
- Occasional domestic and international travel required.
- Occasional weekend work for meetings or inspections.
EQUAL OPPORTUNITY
Outlook Therapeutics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
WHAT WE OFFER
- Competitive base salary. Annual performance bonus
- Generous PTO
- Flexible work environment. Balance remote work with regular in-person collaboration
- In-office time used for planning, workshops, and faster decisions
- Medical, dental, and vision starting day one
- 401(k) with company match
- Paid parental leave
- Travel support for team onsites, launches, and field work
COMPENSATION & BENEFITS
Base salary range $245,000-$285,000 commensurate with experience.
Total compensation includes a competitive benefits package, 401(k) match, and additional perks. Base pay reflects skills, experience, job level, and work location. We balance this with internal equity and current market data.
