Associate Director, Pharmacovigilance, US
SERB Pharmaceuticals, Conshohocken, Pennsylvania, United States
Come and Save Lives with Us!
SERB is a fast‑growing specialty pharmaceutical company that equips healthcare providers worldwide with life‑saving medicines for patients facing rare conditions and emergencies.
For over 30 years we have consistently provided emergency medicines, medical countermeasures, and the world’s leading portfolio of antidotes. Today, SERB has over 500 employees in 18 countries and group revenue in excess of €400m. With a strong presence in the US, Europe, and the Middle East, along with a global network of trusted distribution partners, we make a broad range of essential medicines available in over 100 countries.
We make patients our priority
We act with accountability and integrity
We work together as one team
We look for better ways forward
Job Requisition ID: 32441
Department: SAFETY
Category: Medical - Safety
Location: Philadelphia
Date: 13 Feb 2026
Broad Overview The Associate Director of Pharmacovigilance (PV) in the U.S. is responsible for overseeing the safety and risk management of pharmaceutical products and medical devices throughout their lifecycle. This role ensures compliance with regulatory requirements and internal processes related to drug safety, and collaborates with cross‑functional teams to support patient safety and maintain product integrity. The individual in this role will provide leadership in monitoring, assessing, and reporting adverse events, while ensuring that pharmacovigilance operations align with industry best practices, regulations, and corporate objectives.
Responsibilities Pharmacovigilance Oversight
Lead pharmacovigilance activities for the U.S. territory and assigned products, ensuring adherence to regulatory requirements (FDA, EMA, etc.) and company procedures.
Build a pharmacovigilance function and establish strong relationships with headquarters and U.S. local operations (notably Regulatory and Quality).
Ensure timely collection, processing, and reporting of adverse events, including serious adverse events (SAEs) and non‑serious adverse events (NSAEs).
Review and assess adverse event reports and other safety data to identify trends or signals, and elevate critical issues as needed.
Safety Risk Management
Oversee development and execution of Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and other safety monitoring strategies.
Collaborate with internal and external stakeholders to assess and manage safety risks associated with company products.
Regulatory Compliance
Ensure compliance with applicable pharmacovigilance and medical device regulations, guidelines, and standards (including ICH E2E, FDA, EMA, and all applicable U.S. law).
Maintain a regular watch on local applicable law and regulations and actively contribute to continuous improvement of the pharmacovigilance system.
Maintain up‑to‑date knowledge of regulatory developments and changes in safety reporting requirements.
Prepare and submit periodic safety reports (e.g., PADERs, Annual Reports) in coordination with the regulatory department and in compliance with regulatory timelines.
Cross‑Functional Collaboration
Collaborate with clinical development, medical affairs, regulatory affairs, quality, and other departments to assess product safety and support decision‑making.
Provide safety‑related input into clinical trials, marketing authorization applications (MAAs), and other product development activities.
Training and Organization
Provide training to the Vigilance team on local applicable law and regulation, and on previous experiences for FDA inspections regarding pharmacovigilance and medical device, where applicable.
Vendor Management
Oversee and manage third‑party vendors or contract research organizations (CROs) involved in pharmacovigilance activities.
Ensure that external partners comply with relevant safety standards, contractual obligations, and regulatory requirements.
Data Management and Reporting
Ensure the accuracy and quality of pharmacovigilance data, including implementation of data quality improvement initiatives.
Oversee the preparation of safety data reports and contribute to the overall safety profile of products.
Participate in Due Diligences, specifically for U.S. products.
Internal and External Audits
Lead or participate in internal and external pharmacovigilance audits and inspections, specifically from FDA.
Implement corrective actions to address findings and ensure continuous improvement in PV processes.
The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.
Qualifications
Advanced degree (PhD, PharmD, MD) in life sciences, pharmacology, or related field, or equivalent experience.
Minimum of 8–10 years of experience in pharmacovigilance or drug safety.
In‑depth knowledge of regulatory requirements and guidelines (e.g., FDA, ICH).
Experience with adverse event reporting systems in the USA, PADERs & Annual reports drafting, and signal detection methodologies.
Strong understanding of safety assessments and regulatory reporting.
Proven ability to work cross‑functionally and participate in audits and inspections (including preparation).
Excellent communication and presentation skills.
Strong organizational and project management abilities.
Ability to analyze data and make informed feedback.
Experience working with global teams.
Company Benefits
Hybrid Working
Vacation, personal and sick time
15 paid company holidays
Medical, dental, vision and other voluntary benefits
Paid parental leave
Tuition assistance
Discretionary bonus plan
Competitive 401(k): $1 for $1 up to 6% of pay; safe‑harbour match vested immediately; discretionary match of up to 4% of pay vested 20% a year for 5 years.
EEO Disclaimer SERB is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any protected characteristic protected by federal, state, or local laws. If you require a reasonable accommodation in completing this application, interviewing, completing any pre‑employment requirements, or otherwise participating in the employee selection process, please direct your inquiries to the HR Department.
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SERB is a fast‑growing specialty pharmaceutical company that equips healthcare providers worldwide with life‑saving medicines for patients facing rare conditions and emergencies.
For over 30 years we have consistently provided emergency medicines, medical countermeasures, and the world’s leading portfolio of antidotes. Today, SERB has over 500 employees in 18 countries and group revenue in excess of €400m. With a strong presence in the US, Europe, and the Middle East, along with a global network of trusted distribution partners, we make a broad range of essential medicines available in over 100 countries.
We make patients our priority
We act with accountability and integrity
We work together as one team
We look for better ways forward
Job Requisition ID: 32441
Department: SAFETY
Category: Medical - Safety
Location: Philadelphia
Date: 13 Feb 2026
Broad Overview The Associate Director of Pharmacovigilance (PV) in the U.S. is responsible for overseeing the safety and risk management of pharmaceutical products and medical devices throughout their lifecycle. This role ensures compliance with regulatory requirements and internal processes related to drug safety, and collaborates with cross‑functional teams to support patient safety and maintain product integrity. The individual in this role will provide leadership in monitoring, assessing, and reporting adverse events, while ensuring that pharmacovigilance operations align with industry best practices, regulations, and corporate objectives.
Responsibilities Pharmacovigilance Oversight
Lead pharmacovigilance activities for the U.S. territory and assigned products, ensuring adherence to regulatory requirements (FDA, EMA, etc.) and company procedures.
Build a pharmacovigilance function and establish strong relationships with headquarters and U.S. local operations (notably Regulatory and Quality).
Ensure timely collection, processing, and reporting of adverse events, including serious adverse events (SAEs) and non‑serious adverse events (NSAEs).
Review and assess adverse event reports and other safety data to identify trends or signals, and elevate critical issues as needed.
Safety Risk Management
Oversee development and execution of Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and other safety monitoring strategies.
Collaborate with internal and external stakeholders to assess and manage safety risks associated with company products.
Regulatory Compliance
Ensure compliance with applicable pharmacovigilance and medical device regulations, guidelines, and standards (including ICH E2E, FDA, EMA, and all applicable U.S. law).
Maintain a regular watch on local applicable law and regulations and actively contribute to continuous improvement of the pharmacovigilance system.
Maintain up‑to‑date knowledge of regulatory developments and changes in safety reporting requirements.
Prepare and submit periodic safety reports (e.g., PADERs, Annual Reports) in coordination with the regulatory department and in compliance with regulatory timelines.
Cross‑Functional Collaboration
Collaborate with clinical development, medical affairs, regulatory affairs, quality, and other departments to assess product safety and support decision‑making.
Provide safety‑related input into clinical trials, marketing authorization applications (MAAs), and other product development activities.
Training and Organization
Provide training to the Vigilance team on local applicable law and regulation, and on previous experiences for FDA inspections regarding pharmacovigilance and medical device, where applicable.
Vendor Management
Oversee and manage third‑party vendors or contract research organizations (CROs) involved in pharmacovigilance activities.
Ensure that external partners comply with relevant safety standards, contractual obligations, and regulatory requirements.
Data Management and Reporting
Ensure the accuracy and quality of pharmacovigilance data, including implementation of data quality improvement initiatives.
Oversee the preparation of safety data reports and contribute to the overall safety profile of products.
Participate in Due Diligences, specifically for U.S. products.
Internal and External Audits
Lead or participate in internal and external pharmacovigilance audits and inspections, specifically from FDA.
Implement corrective actions to address findings and ensure continuous improvement in PV processes.
The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.
Qualifications
Advanced degree (PhD, PharmD, MD) in life sciences, pharmacology, or related field, or equivalent experience.
Minimum of 8–10 years of experience in pharmacovigilance or drug safety.
In‑depth knowledge of regulatory requirements and guidelines (e.g., FDA, ICH).
Experience with adverse event reporting systems in the USA, PADERs & Annual reports drafting, and signal detection methodologies.
Strong understanding of safety assessments and regulatory reporting.
Proven ability to work cross‑functionally and participate in audits and inspections (including preparation).
Excellent communication and presentation skills.
Strong organizational and project management abilities.
Ability to analyze data and make informed feedback.
Experience working with global teams.
Company Benefits
Hybrid Working
Vacation, personal and sick time
15 paid company holidays
Medical, dental, vision and other voluntary benefits
Paid parental leave
Tuition assistance
Discretionary bonus plan
Competitive 401(k): $1 for $1 up to 6% of pay; safe‑harbour match vested immediately; discretionary match of up to 4% of pay vested 20% a year for 5 years.
EEO Disclaimer SERB is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any protected characteristic protected by federal, state, or local laws. If you require a reasonable accommodation in completing this application, interviewing, completing any pre‑employment requirements, or otherwise participating in the employee selection process, please direct your inquiries to the HR Department.
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