Pharmacovigilance Onsite Delivery Manager - Digital Operations
Location: Onsite in Cambridge, MA
Cognizant Technology Solutions
We are seeking a strong Pharmacovigilance Delivery Manager to join us in serving a large global pharmaceutical client in Cambridge, MA. You with extraordinary communication skills, both written and verbal, coupled with the ability to communicate effectively in-person with a sophisticated client. You should have excellent leadership capabilities, including being able to bring consensus to global, diverse, cross-functional teams to resolve complex problems. Do you have experience working in clinical research or the pharmaceutical industry? Are you looking to have a positive impact on the quality of life of patients? Are you passionate about helping others while working at the forefront of technological and clinical innovation? Customer focus is at the core of all that we do at Cognizant. Come join us as we partner with our client to lead the way for positive clinical outcomes!
Your primary function will be to ensure that regulatory compliance and submissions are on target per the client's guidelines. You will also be pivotal in ensuring that all Cognizant initiatives meet and exceed the client's expectations. You will partner with an Associate Director leader in India who handles the operations of the program, along with over 130 associates in that region (Calcutta and Mumbai, specifically) including Team Leads and other safety or pharmacovigilance associates and coordinators. You will also work with the Safety Vendor Management and Compliance teams onsite with our client at their headquarters in Cambridge, MA. This industry is dynamic, state of the art, and can make a huge impact in improving the quality of life. Some evening and early morning hours might be required to ensure optimal internal communication and connectivity with both the onshore client teams and offshore Cognizant teams in India.
Your responsibilities will be as follows:
* You will hold regular meetings with onsite and offshore teams on a weekly basis.
* You will continually assess and review quality data metrics.
* You will serve as the primary point-of-contact for client Safety Vendor Management and Compliance Teams as needed to maintain full awareness of concerns, potential risks to shared goals, and changes in expectations.
* You will work our offshore Cognizant teams as well as client to facilitate issues resolution within reasonable timeframe.
You will be assessed on the following performance standards:
* Customer concern Management
* Driving risk identification and mitigation planning
* Communications etiquette
* Inter-personal effectiveness
* Achievement and SLA adherence
* Relationship building with key partners
* Process-driven and customer focus mindset
To be successful, you will need to lead weekly meetings with the client and ensure quality throughout all cases and processes. You will be important to the success of this program. You will be the main point-of-contact for our operations and service delivery questions or customer concerns. You will be able to let your expertise in multiple therapeutic areas shine, including rare diseases, oncology, hematology, as well as your past success running pharmacovigilance programs for Phases I-IV clinical studies. You should also have knowledge of and previous experience working with the ARGUS system, as you will liaise with the onsite IT team for validations and other related IT processes.
You should be a self-starter, capable of handling high-level executive communications with gravitas and finesse, and the ability to bring consensus amongst global, teams with varied strengths between two different companies. You should be a strong leader with a focus on accuracy, process improvement excellence, and precise adherence to client and regulatory expectations during times of high stress and high pressure.
The basic qualifications of the role are the following:
* Graduate, Post Graduate, or Doctorate degree in Life sciences/ Pharmacy/Medical sciences or any other related field.
* A minimum of 10 years of experience in a global CRO, BPO, BPS or consulting experience within the Pharmaceutical or Clinical Research industry.
Our strength is built on our ability to work together. Our diverse backgrounds offer different perspectives and new ways of thinking. It encourages lively discussions, inspires thought leadership, and helps us build better solutions for our clients. We want someone who thrives in this setting and is inspired to craft meaningful solutions through true collaboration.
If you're comfortable with ambiguity, excited by change, and excel through autonomy, we'd love to hear from you.
Cognizant is a provider of information technology, consulting, and business process outsourcing services.