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 a Sr. Director, Pharmacovigilance Science and Operations in Cambridge, MA

Role Description

• Provide oversight and review of vendor case processing activities, including tracking of key performance indicators, compliance oversight, etc.
• Oversee vendor responsible for preparation of monthly metrics, aggregate reports, including training.
• Oversee the PV vendors/service providers to ensure that they fulfill their accountabilities and responsibilities for all outsourced PV activities
• Assume Aggregate Safety Lead role in DSUR and other aggregate report activities
• Perform quality review of ICSRS, including drafting of AOSE for SUSARs.
• Support SAE reconciliation activities and preparation of SMPs.
• Support the preparation of SDEAs, SRPs, PVAs, and data entry guidelines.
• Support the review of MedDRA upgrade impact assessment and developing CRF pages.
• Support drafting of meeting minutes, and safety reporting language for Protocols and ICFs.
• Participate in a new study initiation to ensure PV requirements were met, including but not limited to safety reporting, query resolution, SAE reconciliation, and un-blinding process.
• Participate in developing and maintaining PV System policies, SOP forms, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, & GVP.
• Represent Pharmacovigilance in cross-functional activities to ensure and promote compliance with pharmacovigilance data collection standards and operational consistency across clinical trials and commercial programs for all products.
• Oversee the activities for monitoring adverse event reports for potential drug-safety-related issues and provide recommendations when potential issues are identified.

Skills & Requirements

• At least 15 years in biotech/pharmaceutical industry/CRO with at least 10 yrs in safety surveillance and risk management regulatory authorities.
• Prior experience as Aggregate Safety Lead in overseeing multiple and/or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines I required.
• Supporting developing and reviewing appropriate safety sections of key product documents, including IBs (RSI determination), study protocols, ICF, CSRs, CCDS, and RMPs.
• Preparing and presenting DSMB slides, Safety Management Teams and other safety governance procedures
• Reviewing TFLs and AE data from ongoing studies to evaluate common AE lab abnormalities and summarize the results in the product safety reports.
• Performing literature surveillance, identifying safety issues from published medical literature and
• Summarizing relevant publications for inclusion in safety periodic reports
• PharmD, BSN, NP, PA, MD, or equivalent training . MPH is preferred but not required.
• Tools: Argus, Arisg, MedDRA, Document Repositories, SAS, Tableau, Argus, Spotfire, EMPIRICA

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.

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