Job title: Team Lead/Consultant-Pharmacovigilance
Company: Accenture
Job description: Skill required: Pharmacovigilance – Medical Review
Designation: Team Lead/Consultant
Job Location: Bengaluru
Qualifications: Any Graduation
Years of Experience: 7-11 years
About Accenture Operations
Accenture is a global professional services company with leading capabilities in digital, cloud and security. Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Interactive, Technology and Operations services all powered by the world s largest network of Advanced Technology and Intelligent Operations centers. Our 624,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com
What would you do
You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings – Clinical, Pharmacovigilance & Regulatory, helping the world s leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.
You will be part of a dynamic Pharmacovigilance team with array of capabilities ranging from detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem following Good Pharmacovigilance Practice (GVP) per client SOPs and applicable global regulatory requirements (Individual Case Safety Reports) to working on various aspects of Aggregate reports such as planning, authoring, reviewing and publishing of PBRER, PSUR, DSUR, PADER, Addendum to clinical overview (AdCO), Risk Management Plan (RMP), Signal detection and validation reports (SDVR), Cosmetovigilance Safety Reports (CoSR). The Pharmacovigilance team is also responsible for authoring and reviewing clinical documents such Protocols and amendment, Investigator Brochure, Clinical Study Reports (CSR), Synoptic/Abbreviated CSR, Safety Narratives, Clinical Overview/abbreviated Clinical Overview.
You will be expected to collect and perform a clinical review of medical records and related information to ensure that payment is made only for services that meet all Medicare coverage, coding, billing, and medical necessity requirements. Review and assessment of seriousness, causality, and labeling/expectedness of adverse events of individual case safety report in compliance with client standard operating procedures and global regulatory requirements.
What are we looking for
We are looking for individuals who have the following skillset:
- Adaptable and flexible
- Problem-solving skills
- Detail orientation
- Ability to establish strong client relationship
Roles and Responsibilities
- In this role, you need to analyze and solve moderately complex problems
- You are required to create new solutions, leveraging and, where needed, adapting existing methods and procedures
- You are required to understand the strategic direction set by senior management, clearly communicate team goals, deliverables, and keep the team updated on change
- Your primary upward interactions are with your direct supervisor
- You may interact with peers and/or management levels at a client and/or within Accenture
- You will be provided with guidance when determining methods and procedures on new assignments
- The decisions that are made by you will often impact your team
- You would be an individual contributor and/or oversee a small work effort and/or team.
Please note this role may require you to work in rotational shifts. ,
Other details
Expected salary:
Location: Bangalore, Karnataka
Job date: Sat, 18 Dec 2021 08:01:14 GMT
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