29 June, 2022
Accenture Hiring General Manager – Pharmacovigilance Services
Skill required: Pharmacovigilance – Medical Review
Designation: General Manager – Pharmacovigilance Services
Job Location: Bengaluru
Qualifications: Any Graduation
Years of Experience: 10-14 years
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.
You will be expected to collect and perform a clinical review of medical records and related information to ensure that payment is made only for services that meet all Medicare coverage, coding, billing, and medical necessity requirements. Review and assessment of seriousness, causality, and labeling/expectedness of adverse events of individual case safety report in compliance with client standard operating procedures and 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.