Executive Director, Pharmacovigilance (PV) at SAB Biotherapeutics | chakrie

Requirements

Additional Requirements

Doctor of Medicine (MD) degree from an accredited institution is required.
12+ years of progressive pharmaceutical/biotech industry pharmacovigilance experience, with at least 5 years in a senior role with direct accountability for late-phase global biologics PV programs.
Demonstrated hands-on authorship of Integrated Safety Summaries (ISS) submitted in at least one BLA or MAA; experience with multiple submissions strongly preferred.
Extensive experience authoring CSR safety sections, DSURs, and PSURs/PBRERs for biologic compounds in global development.
Deep command of ICH guidelines (E2A–E2E, E6, E8, M4E), FDA/CDER and EMA/EMA GVP Module requirements, and regional pharmacovigilance regulations (EU, US, Japan, and other ICH regions).
Extensive experience with signal detection methodologies, benefit-risk assessment frameworks, and safety narrative writing.
Proven track record managing CRO/vendor PV relationships and safety database oversight (Argus, ARISg, or equivalent).
Experience in small biotech or start-up environments is desired; comfortable operating with limited infrastructure and high personal accountability.
Experience with BLA or MAA approval for a biologic; post-approval PV experience a plus.
Familiarity with rare disease, orphan drug, or first-in-class biologic programs.
Experience presenting to Health Authorities (FDA, EMA) and participation in Advisory Committee proceedings.
Familiarity with REMS design and implementation or EU RMP preparation.
Knowledge of pharmacoepidemiology methodologies and real-world evidence applications in safety assessment.
Exceptional scientific and medical writing ability; proven capacity to synthesize complex safety data into clear, structured regulatory documents under tight timelines.
Strong analytical and critical thinking skills; ability to independently evaluate complex safety signals and formulate evidence-based recommendations.
High scientific credibility with the ability to engage and challenge clinical, statistical, and regulatory colleagues at a peer level.
Excellent project management skills; able to manage multiple competing priorities without sacrificing quality.
Demonstrated leadership and cross-functional collaboration is crucial.
While performing the duties of this job
the employee is regularly required to walk
and sit. The employee must regularly lift and
or move up to 10 pounds.
Home office working environment.
Domestic and International business related to travel (estimated 10–20%). Travel will include team meetings
and conference participation.
The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.
SAB BIO is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB BIO is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race
non-disqualifying physical or mental disability
veteran status or any other legally protected status. EOE

Responsibilities

A clear overview of what is expected, written by the people who posted it, with every detail you need to decide.

Qualifications, experience and the skills that matter most, along with anything that would make you stand out.

Practical next steps, the documents to prepare and the dates to keep in mind before you apply or get in touch.

Contact details, links to the official source and the notes our team adds after checking each listing by hand.

Skills & expertise

Qualifications, experience and the skills that matter most, along with anything that would make you stand out.

Practical next steps, the documents to prepare and the dates to keep in mind before you apply or get in touch.

Contact details, links to the official source and the notes our team adds after checking each listing by hand.

Everything else on this page, kept up to date and available to every member of Chakrie at no cost at all.

Salary & benefits

A clear overview of what is expected, written by the people who posted it, with every detail you need to decide.

Qualifications, experience and the skills that matter most, along with anything that would make you stand out.

Practical next steps, the documents to prepare and the dates to keep in mind before you apply or get in touch.

Contact details, links to the official source and the notes our team adds after checking each listing by hand.

Members only · Free to join

Sign in to see the full job details

See every requirement, the benefits, exactly how to apply and who you would be working for.

Responsibilities
Skills & expertise
Salary & benefits
How to apply
Company information

Executive Director, Pharmacovigilance (PV)

Summary

Requirements

Additional Requirements

Sign in to see the full job details

Report this Job / Company (রিপোর্ট)

Summary

Requirements

Additional Requirements

Sign in to see the full job details

Report this Job / Company (রিপোর্ট)

Similar jobs