Skill required: Pharmacovigilance – Clinical & Regulatory Writing
Designation: Team Lead/Consultant
Job Location: Bengaluru
Qualifications: Master of Pharmacy
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 674,000 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 Pharmaceuticals Processes vertical and help us with the processes to collect, monitor, research, assess and evaluate information on the adverse effects of medication with a view to identifying new information about hazards associated with medicines and consequently, prevent harm to patients. It also deals with the reviewing and resolving of discrepancies identified by the system or through manual checks as per guidelines. Employees under this span can also be responsible for a number of activities related to the design, development, and maintenance of Clinical Database objects.
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.
In this role, you will be expected to produce variety of clinical documents throughout the lifecycle of a (potential) treatment, starting with describing and reporting data from clinical trials, through to preparing regulatory submission documents including post approval reports.
What are we looking for?
We are looking for individuals who have the following skillset:
Pharmaceutical Drug Safety Surveillance
Pharmacovigilance and Drug Safety Surveillance
Adaptable and flexible
Ability to perform under pressure
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.
Apply through this Link