Description
Kelly® Science & Clinical is seeking a Medical Director of Pharmacovigilance for a fulltime, Direct Hire role with a pharmaceutical client based in the San Fran Bay area. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Position: Director, Pharmacovigilance
Operations Location: Remote
Department: Clinical R&D
Employment Type: Full-time, Direct Hire
Compensation: $260,000-$290,000 plus annual bonus and equity
Position Overview:
The Director, Pharmacovigilance is responsible for leading global drug safety activities, ensuring compliance with regulatory requirements for adverse event (AE) reporting, and maintaining the integrity of safety data across clinical and post-marketing programs. This role oversees the timely and accurate submission of safety reports to health authorities, manages signal detection and risk assessment processes, and provides strategic input into safety management plans. The Director also leads cross- functional safety data reviews, collaborates with regulatory and clinical teams, and ensures continuous improvement of PV (pharmacovigilance) systems and procedures to uphold patient safety and regulatory standards. This role supports the development, implementation, and delivery of PV strategy for assigned projects, ensuring alignment with timelines, budgets, and quality standards. In the area of PV, the physician is expected to contribute to the overall strategy and approach within Medical Safety by assisting the department head. Note this position requires a Doctor of Medicine (MD).
This is a full-time position and may be performed remotely from any location within the continental U.S. The position will report to Senior Director, Medical Monitoring and Pharmacovigilance.
Key Duties& Responsibilities:
Key responsibilities of this role include, but are not limited to:
- The successful candidate will provide PV technical support to one or more Clinical Project Teams to ensure the successful design and implementation of Clinical Development Plans.
- Major areas of responsibility include contributions to PV clinical data safety analysis and regulatory submissions.
- Reviews of clinical safety trial-related documents, such as CRF, PD, and MM Plan.
- Ensure PV Medical Safety activities are performed in compliance with all applicable regulations and our client's standards.
- Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, annual reports (DSUR), final study reports, IB and other documents as needed.
- Assist with development of Risk Management Plans, implementation and evaluation of their effectiveness.
- Ensure safety issues are communicated to the appropriate stakeholders in a timely fashion.
- Author analysis of similar events(AOSE) and individual case comments for ICSRs.
- Maintain knowledge of global regulatory authority regulations including FDA.
- Represent and advise on Clinical Safety in team meetings.
- Establish good working relationships with investigators.
- Serve as a point of contact for trial sites for medical issues in clinical trials.
- Review and respond to questions from the trial sites regarding any safety queries, such as eligibility, laboratory findings, ECG, and concomitant medications; and maintain a medical decision log.
- Represent safety during Site Initiation Visits, Investigator Meetings, CROs ,and other collaborators as requested.
- Collaborate in data cleaning activities, and development of Tables, Listings and Figures (TLFs) before database lock.
- Develop the proposed clinical milestones with the Clinical Sub-team.
- Develop strategies, working with the Head of Safety, to achieve PV Medical Safety goals.
- Along with the Head of Safety, represent PV in communications with health authorities such as the FDA.
- Assess safety signals and trends and proactively manage any potential safety issues.
- Organize Safety Management meetings (SMM) to maintain a periodic analysis of study-related safety data in sponsored clinical trials, assessing safety concerns, anomalies, trends, and discrepancies.
- Formulate response strategies and author responses for PV-related health authority requests.
- Assist with Medical Monitoring as needed on clinical trials.
- Assist with oversight of the vendor performing medical review of ICSRs and aggregate report on behalf of our client.
- Perform medical review of serious adverse events from clinical trials and lead the development of SAE narratives in collaboration with the CRO and our client.
- Accountable for medical evaluation/interpretation of aggregate safety data of assignment product(s) including signal detection and evaluation, and ad hoc safety assessments.
- Provide oversight for the safety aspects for clinical studies, and development and maintenance of the company's core safety information.
Qualifications:
- MD required, neurology, psychiatry, or CND-related disease experience is a plus.
- Minimum 5 years of relevant drug safety experience in the pharmaceutical industry, or equivalent.
- Highly developed scientific and analytical knowledgebase and an excellent understanding of good pharmacovigilance practices and current regulations within drug safety.
- Working knowledge of validated drug safety databases, MedDRA and WHO.
- Thorough understanding of U.S. pharmacovigilance regulations, GCP and International Conference on Harmonization (ICH) guidelines.
- Extensive experience in authoring all types of aggregate safety reports including setting a strategy to address potential safety issues.
- In-depth understanding of the drug development process.
- Exceptional written and verbal communication skills.
- Ability to build and sustain trusted relationships both internally and externally.
- Proficient computer skills including Microsoft Word, PowerPoint, and Excel.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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