Senior Medical Director, Pharmacovigilance
SiteOne Therapeutics
San Francisco, CA, USA · South San Francisco, CA, USA
USD 320k-335k / year
Posted on May 7, 2025
SiteOne Therapeutics is a clinical-stage biopharmaceutical company advancing a novel class of highly selective small molecule inhibitors targeting NaV1.7, NaV1.8, and other ion channels to treat pain, cough and other conditions involving hyperexcitability of the peripheral nervous system. Since its inception, SiteOne has been dedicated to the development of safe and effective pain therapeutics without the significant addiction potential and side effects of opioids. The company is also advancing additional novel drug candidates that exhibit precise selectivity for individual ion channel subtypes to treat other sensory hyperexcitability disorders such as chronic cough and chronic ocular surface pain.
Summary
We are currently searching for an experienced professional to join our team as Senior Medical Director, Pharmacovigilance.
Reporting to the Chief Medical Officer, the Senior Medical Director of Pharmacovigilance (PV) Physician will provide strategic leadership and oversight for pharmacovigilance activities, ensuring the safety of the company’s products throughout their lifecycle. The role involves close collaboration with cross-functional teams, including clinical development, regulatory affairs, and medical affairs, to identify, assess, and communicate safety risks. The Senior Medical Director will also lead safety evaluations, manage benefit-risk assessments, and contribute to regulatory submissions and safety compliance globally.
Key Responsibilities
SiteOne Therapeutics is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Agency Disclaimer: SiteOne Therapeutics does not accept unsolicited resumes from recruiters or agencies. We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file. Therefore, please do not submit resumes unless authorized. SiteOne Therapeutics will not pay any fees related to unsolicited resumes, including those submitted to hiring managers.
Base Salary Range
$320,000—$335,000 USD
Summary
We are currently searching for an experienced professional to join our team as Senior Medical Director, Pharmacovigilance.
Reporting to the Chief Medical Officer, the Senior Medical Director of Pharmacovigilance (PV) Physician will provide strategic leadership and oversight for pharmacovigilance activities, ensuring the safety of the company’s products throughout their lifecycle. The role involves close collaboration with cross-functional teams, including clinical development, regulatory affairs, and medical affairs, to identify, assess, and communicate safety risks. The Senior Medical Director will also lead safety evaluations, manage benefit-risk assessments, and contribute to regulatory submissions and safety compliance globally.
Key Responsibilities
- Responsible for developing and implementing the pharmacovigilance strategy for all assets in development
- Serve as the safety lead for assigned products, providing medical expertise on safety-related matters.
- Ensure the integration of safety data into overall clinical and regulatory strategies.
- Lead signal detection activities, including the review and analysis of safety data from clinical trials, post-marketing surveillance, and real-world data.
- Oversee the development and maintenance of risk management plans (RMPs) and periodic safety update reports (PSURs).
- Provide medical oversight for the evaluation of adverse events (AE) and serious adverse events (SAE) reports, including causality assessments and regulatory reporting.
- Ensure compliance with global PV regulations, including FDA, EMA, and ICH guidelines.
- Contribute to the preparation of regulatory documents, including INDs, NDAs, MAAs, DSURs, and safety sections of clinical study reports (CSRs).
- Act as a key point of contact with regulatory authorities for safety-related inquiries.
- Collaborate with clinical development teams to design and monitor clinical trial safety protocols.
- Work with medical affairs to develop safety communication strategies, including risk mitigation and product labeling updates.
- Partner with biostatistics and data management teams to analyze and interpret safety data.
- Manage and mentor pharmacovigilance staff, fostering professional development and ensuring the quality of deliverables.
- Lead pharmacovigilance committees, such as the Safety Management Team (SMT), and participate in Data Safety Monitoring Boards (DSMBs) as required.
- Provide timely and accurate communication of safety risks to senior management, external stakeholders, and regulatory authorities.
- Lead safety signal evaluations, including recommendations for actions such as protocol amendments, regulatory updates, or product withdrawals.
- Medical Degree (MD) or equivalent required; board certification preferred.
- Minimum 10 years of pharmacovigilance experience, with demonstrated leadership in drug safety.
- Experience with clinical development and post-marketing safety activities in the biopharmaceutical industry.
- In-depth knowledge of global pharmacovigilance regulations and guidelines (FDA, EMA, ICH).
- Expertise in benefit-risk assessment and signal detection methodologies.
- Experience with safety databases (e.g., Argus, ARISg, or Veeva Safety) preferred.
- Prior experience interacting with regulatory authorities (e.g., FDA, EMA) preferred.
- Strong analytical skills with the ability to interpret complex safety data.
- Excellent written and verbal communication skills, including experience with regulatory documents and safety reports.
- Leadership and team management experience with a track record of mentoring professionals.
- Ability to work effectively in cross-functional and global teams.
- High attention to detail and organizational skills with the ability to manage multiple priorities.
- Available to travel periodically for in person onsite office meetings and engagement meetings with regulatory
SiteOne Therapeutics is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Agency Disclaimer: SiteOne Therapeutics does not accept unsolicited resumes from recruiters or agencies. We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file. Therefore, please do not submit resumes unless authorized. SiteOne Therapeutics will not pay any fees related to unsolicited resumes, including those submitted to hiring managers.
Base Salary Range
$320,000—$335,000 USD