Associate Vice President - Pharmacovigilance and Drug Safety Surveillance

Job Requirements You will be aligned with our Life Sciences R&D vertical. Our services span 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 an 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 (CSR).The Pharmacovigilance team is also responsible for authoring and reviewing clinical documents such as Protocols and amendments, Investigator Brochure, Clinical Study Reports (CSR), Synoptic/Abbreviated CSR, Safety Narratives, Clinical Overview/abbreviated Clinical Overviews.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. Work Experience Adaptable and flexibleAbility to perform under pressureAbility to establish a strong client relationshipIn this role, you need to analyze and solve moderately complex problemsYou will typically be creating new solutions, leveraging and, where needed, adapting existing methods and proceduresThe role requires a clear understanding of the strategic direction set by senior management as it relates to team goalsYou will need to hold monthly meaningful conversations with team members to discuss performance, coaching and feedback, training needs, and career discussionsYou will need to monitor & drive team performance, including throughput and quality as per the defined metricsYour primary upward interaction is with a direct supervisor or team leadsYou will generally interact with peers and management levels with clients or internal stakeholdersYou will be provided with minimal guidance when determining methods and procedures for new assignmentsDecisions that you make often impact the team in which they reside and occasionally move other teamsYou would manage medium-small-sized teams and work efforts at a client or within Accenture. Associate Vice President - Pharmacovigilance and Drug Safety Surveillance, Accenture, Chennai .