Associate Manager-Pharmaceuticals Processes

  Regulatory Affairs

Job title: Associate Manager-Pharmaceuticals Processes

Company: Accenture

Job description: Skill required: Pharmacovigilance – Medical Affairs Designation: Associate Manager About Accenture Operations Accenture is a global professional services company with leading capabilities in digital, cloud and security. Combining unmatched experienc

Skill required: Pharmacovigilance – Medical Affairs Designation: Associate Manager 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 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 Medical Affairs, you will have to design, develop and deliver business solutions related to the medical affairs group of pharmaceutical companies, including thought leadership development, medical publications, education and information, medical grants, advisory boards and advocacy, regulatory review and approval of pharmaceutical drugs and perform publishing and quality control tasks on submission components. What are we looking for? We are looking for individuals who have the following skillset: Adaptable and flexible Ability to perform under pressure Ability to establish strong client relationship Roles and Responsibilities In this role, you need to analyze and solve moderately complex problems You will typically be creating new solutions, leveraging and, where needed, adapting existing methods and procedures The role requires a clear understanding of the strategic direction set by senior management as it relates to team goals You will need to hold monthly meaningful conversations with team members to discuss performance, coaching and feedback, training needs, and career discussions You will need to monitor & drive team performance, including throughput and quality as per defined metrics Your primary upward interaction is with a direct supervisor or team leads You will generally interact with peers and/or management levels with clients or internal stakeholders You will be provided with minimal guidance when determining methods and procedures on new assignments Decisions that you make often impact the team in which they reside and occasionally impact other teams You would be managing medium-small d teams and/or work efforts at a client or within Accenture. Please note this role may require you to work in rotational shifts.

Expected salary:

Location: Chennai, Tamil Nadu

Job date: Mon, 24 Jan 2022 23:40:51 GMT

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