Pharmacovigilance Operations Associate
Compensation: $164,410.00 - $164,410.00 /year *
Employment Type: Full-Time
Industry: Scientific Research
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Kelly Scientific Resources is a specialty service of Kelly Services . As the world's largest provider of HR solutions to the scientific community, Kelly Scientific Resources is focused exclusively on placing skilled scientific professionals in contract, contract-to-hire, and full-time science jobs across a full spectrum of related industries and disciplines. Our scientists contribute to the research and development of therapeutics that change the lives of those affected with disease. We have an exciting contract opportunity in So San Francisco for a PV Operations Associate to join a leading biotherapeutics client. Pharmacovigilance Operations Associate Supports all MAP Operations related activities
- Perform reconciliation related activities for Market Research Patient (MAP) support programs and responsible for tasks related to MAP Global Tracking Tool (GTT) to ensure continuous data integrity.
- Run operational metrics reports on a routine basis, identify follow-up s required, and work with the appropriate PV Operations head and/or vendor lead to ensure appropriate follow-up is completed.
- Oversees operational aspects of US MAP Service Provider Qualification Process including: curation and upkeep of US MAP Service Provider qualification portal, ensuring consistency and fidelity of all Service Provider lists, management and assignment of new assessments to PV Operations head and/or vendor lead
- Responsible for executing Source Data QC (SDQC) of in scope MAPs on a quarterly basis. This includes: a) Communication with MAP vendors; b) management of vendor conducting SDQC, including appropriate QC; receiving, QC and tracking data files.
- Supports all study management related activities
- Responsible for oversight, triage, and tracking of incoming study document review request
- Responsible for performing Case Transmission Verification (CTV)
- Ensuring all USMA studies have been reviewed by PV Clinical Group
- Performs Outbound Submission and Tracking (OST) for literature ICSRs and submits relevant documentation to health authority
- Identifies compliance trends and formulates action plan as needed to address compliance issues.
Skills: Competencies Identified for Success:
- Ability to translate complex data trends to actionable steps
- Demonstrates strong business expertise related to PV environment
- Works effectively, independently and collaboratively.
- Strong organizational skills, detail oriented and adapts in a fast paced, changing environment.
- Demonstrates ownership, initiative and accountability.
- Excellent communication skills, both written and verbal.
- Able to translate complex tasks and execute in a timely manner to ensure compliance
- Ability to prioritize tasks in a timely manner.
- Ability to interact effectively in a multifunctional, multidisciplinary team setting.
- Sound decision making abilities as demonstrated by systematic gathering of information, appropriately assessing the complexity of issues, and prioritization of tasks in a timely manner within the scope of responsibility.
- Ability to actively exchange knowledge and ideas.
- Demonstrates leadership skills.
- Can be recent graduate.
- Minimum Bachelor s degree (Preferred)
- Degree in Life Science or related field (Preferred)
- Demonstrates expertise in computer skills and database experience (i.e Microsoft office Suite) (Preferred).
- Writing experience; science/medical writing highly desirable.
- Ability to travel as required
- Health Care Professional NOT required
As a worker today, it s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what s next is what we re all about. We know what s going on in the evolving world of work just ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.
At Kelly, we re always thinking about what s next and advising job seekers on new ways of working to reach their full potential. In fact, we re a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.Job Requirements:
Associated topics: cytometry, histologist, immuno oncology, immunology, kinesiology, medicine, microbiological, nutrition, vaccine, virus
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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