Associate Manager-Pharmaceuticals Processes

Job Description

Skill required: Pharmacovigilance - Pharmacovigilance and Drug Safety Surveillance Designation: Associate Manager Job Location: Chennai Qualifications: Any Graduation Years of Experience: 10-14 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 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.In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. 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 sized teams and/or work efforts at a client or within Accenture.
Please note this role may require you to work in rotational shifts.,

Keyskills :
salesmanagementmiscustomer relationsqualitydata entrydrug safetylife sciencesstudy reportstraining needsrisk managementclinical trialscase processingbusiness processteam performance