PV Operations Associate
350 DNA Way South San Francisco, CA 94080
Bayside Solutions is seeking a PV Operations Associate to be part of our client’ s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
PV Operations Associate:
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- 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.
Summary of Qualifications:
- Minimum Bachelor’ s degree (Preferred) or 12-15 years PV experience.
- 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.
- 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.