Manager-Pharmaceuticals Processes

  Regulatory Affairs

Job title: Manager-Pharmaceuticals Processes

Company: Accenture

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

Skill required: Pharmacovigilance – Medical Affairs Designation: 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: Ability to perform under pressure Ability to establish strong client relationship Ability to manage multiple stakeholders Roles and Responsibilities In this role you are required to identify and assess complex problems for area of responsibility You will need to create solutions in situations which requires an in-depth analysis/evaluation of variable factors This will require alignment to strategic direction set by senior management when establishing near-term goals Your primary interaction will be with senior management at a client and/or within Accenture, involving matters that may require acceptance of an alternate approach Some latitude in decision-making is involved, you will act independently to determine methods and procedures on new assignments You will need to flag risks to clients and Accenture stakeholders and propose action plans where needed You will need to have an innovative mindset to identify improvement opportunities to optimize processes, decrease costs and increase client value Decisions that you make in this role will have a major day to day impact on area of responsibility You will be managing medium – large d teams and/or work efforts at a client or within Accenture You would require transformation mindset and eye for identifying automation/process improvement opportunities. Please note this role may require you to work in rotational shifts.

Expected salary:

Location: Hyderabad, Telangana

Job date: Fri, 28 Jan 2022 23:52:15 GMT

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