The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available.

Our client is seeking an Associate Director, Pharmacovigilance, US in Philadelphia, PA.

Role Description

Pharmacovigilance Oversight:
• Lead the pharmacovigilance activities for the US territory and for assigned products in the U.S., ensuring adherence to regulatory requirements (FDA, EMA, etc.) and company procedures.
• Participate to build a pharmacovigilance function and build strong relationships with headquarter and US local operations (notably Regulatory and Quality)
• Ensure the 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 escalate critical issues as needed.

Safety Risk Management:
• Oversee the 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 regulations and medical device regulations, guidelines, and standards (including ICH E2E, FDA, EMA, and all applicable law and regulation in US).
• Ensure a regular watch on local applicable law and regulations and participate actively to the 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 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.

Trainings and organization:
• Provide training to the Vigilance team, for the local applicable law and regulation and from 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 the implementation of data quality improvement initiatives.
• Oversee the preparation of safety data reports and contribute to the overall safety profile of products.
• Participate to Due Diligences, specifically for US 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.

Skills & Requirements

• 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 to audits and inspections (including the 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

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

#LI-DNI