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New · posted Oct 31

Orca Bio · Biotechnology

Director/Head, Pharmacovigilance

  • Remote, US); Menlo Park, CA
  • Remote
  • Full-time
  • Director
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Pay$200K–$245K
EmploymentFull-time
LocationRemote, US); Menlo Park, CA
LevelDirector
FunctionClinical Safety & Pharmacovigilance
DeadlineOpen until filled

The role

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

Position Summary: Reporting to our Chief Development Officer, the Director/Head of Pharmacovigilance will lead and develop the safety function, providing direct guidance to a small, dedicated team while driving end-to-end operational oversight.

What you need

  • MD Required
  • 10+ years of experience in drug safety, safety science and risk management at a pharmaceutical, biotech, or CRO, including people leadership experience.
  • Knowledge of US and EU safety regulations pre and post marketing pharmacovigilance requirements.
  • Experience with pharmacovigilance risk management, preferably at a commercial-stage company.
  • Proficiency in preparing pre-marketing and post marketing safety regulatory documents, including PSURs, PBRERs, PADER, and Risk Management Plans.
  • Experience with clinical development, risk/benefit analysis, and safety assessment.
  • Strong clinical, analytical, problem-solving, scientific writing, and communication skills.
  • Prior experience working on a BLA/NDA. Prior experience leading risk management activities for a BLA/NDA preferred.
  • Hands-on mentality, ability to operate in a small biotech environment.
  • Knowledge of cell therapy, bone marrow transplant or hematology oncology is a plus.
  • Expertise in analyzing safety data from clinical and safety databases.
  • Experience in MedDRA coding and search strategies.
  • Excellent independent judgment based on knowledge and expertise.
  • Strong personal time management and project management skills.

    • The anticipated annual salary range (listed above) for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.

    Skills named in this posting

    What you'll do

  • Lead risk management and mitigation activities for assigned products, leading safety data review and analysis for all products.
  • Responsible for providing safety-related content for all clinical and regulatory documents.
  • Lead inspection preparedness efforts for pharmacovigilance and represent Orca’s pharmacovigilance organization at regulatory inspections.
  • Stay abreast of changes in regulations, leading updates to SOPs and other documentation to address any process gaps.
  • Identify and address resource and infrastructure needs, contribute to departmental budgets and planning to align with Orca products’ stage of development.
  • Represent product safety in the cross-functional team environment.
  • Lead safety governance activities in collaboration with medical monitors and leadership.
  • Lead safety related activities for regulatory filings including development of meeting request and briefing book content, SAP and TFL review, signal detection and risk identification, responses to regulatory queries, RMPs, REMs, ISS strategy, and regional safety related labeling activities.
  • Provide guidance and mentorship to all direct reports within the pharmacovigilance function, including support and oversight of operations.

    • Pay and benefits

    $200,000 – $245,000 a year

    Employer provided
    How this compares

    • Pre-IPO equity

    • Annual bonus

    • Medical, dental and vision

    • PTO

    • 401(k) plan

    • Parental leave

    Dozens of Orca Bio colleagues in hard hats and safety vests waving inside a large manufacturing space

    From the posting

    About Orca Bio

    We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

    We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

    We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.

    We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

    Orca Bio company page · 6 open roles
    Equal opportunity, accessibility and legal noticesOrca Bio's statements, word for word

    Notice to staffing firms

    Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

    We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

    Job intelligence

    The context around this role

    Live data · October 31, 2026

    Salary intelligence

    How the pay compares

    This role's midpoint is 14% below the US median for Clinical Safety & Pharmacovigilance roles at this level.

    This roleEmployer provided

    $200,000 to $245,000 a year

    Director roles in California18 roles publishing pay

    Middle half $227,125 to $280,750, median $254,250

    Director roles in the US69 roles publishing pay

    Middle half $213,500 to $281,000, median $260,000
    Annual base pay
    Annual base payLowMedianHigh
    This role$200,000—$245,000
    California$227,125$254,250$280,750
    All US$213,500$260,000$281,000

    This role: Orca Bio's own published range. Comparisons: the base pay employers published on open Clinical Safety & Pharmacovigilance roles at the same level on Regulatory Jobs, October 31, 2026. Nothing is estimated.

    Career trajectory

    Where this role sits in Clinical Safety & Pharmacovigilance

    The general path across 113 open Clinical Safety & Pharmacovigilance roles on Regulatory Jobs, with the titles they carry most. Not Orca Bio's own promotion track.

    1. Earlier

      Associate & Specialist

      Often: Associate, Pharmacovigilance Operations/Drug Safety · Clinical Sciences Partnership COE Coordinator

      5 open

    2. Earlier

      Senior & Principal

      Often: Senior Safety Scientist · Clinical FSP Quality Manager

      $186K median11 open

    3. One step back

      Manager

      Often: Senior Manager, Clinical Quality Assurance · Clinical FSP Quality Manager

      $170K median15 open

    4. This role

      Director

      Often: Director · Senior Medical Director

      $260K median70 open

    5. Next step

      VP & Executive

      Often: Head of Multiple Myeloma & AML, Oncology · Head of Patient-Facing Quality Assurance

      $347K median12 open

    Skills DNA

    What this role leans on

    How many of the posting's 5 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

    GMP and compliance: 2 linesLab testing and methods: 1 lineDocumentation and SOPs: 2 linesRegulatory submissions: 2 linesQuality systems and risk: 2 linesData and digital systems: 1 lineClinical trial conduct: 1 lineCollaboration and leadership: 4 linesGMPLab testingDocumentationSubmissionsQuality systemsData systemsClinical trialsTeamwork
    • Collaboration and leadership4
    • GMP and compliance2
    • Documentation and SOPs2
    • Regulatory submissions2
    • Quality systems and risk2
    • Lab testing and methods1
    • Data and digital systems1
    • Clinical trial conduct1

    Regulatory intelligence

    The rules behind this role

    Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.

    From Regulatory News

    Manufacturing and quality coverage for this profession

    Company hiring pulse

    Orca Bio on Regulatory Jobs

    6
    Open roles
    6
    Distinct roles
    4
    Locations

    By discipline

    • Clinical4 67%
    • Regulatory1 17%
    • Quality1 17%

    By level

    • Director3 50%
    • Associate & Specialist2 33%
    • Manager1 17%
    See all 6 Orca Bio roles

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    Similar Clinical Safety & Pharmacovigilance roles elsewhere

    Director/Head, Pharmacovigilance at Orca Bio

    Open until filled. $200K–$245K a year, employer provided.

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