Pharmacovigilance Services Specialist-Pharmacovigilance

Skill required:Pharmacovigilance - Medical Review
Designation:Senior Medical Review Scientist
Job Location:Chennai
Qualifications:MBBS
Years of Experience:7 to 11 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?

Ability to handle disputes

Ability to manage multiple stakeholders

Ability to perform under pressure

Adaptable and flexible

Collaboration and interpersonal skills Roles and Responsibilities

In this role you are required to do analysis and solving of moderately complex problems

May create new solutions, leveraging and, where needed, adapting existing methods and procedures

The person would require understanding of the strategic direction set by senior management as it relates to team goals

Primary upward interaction is with direct supervisor

May interact with peers and/or management levels at a client and/or within Accenture

Guidance would be provided when determining methods and procedures on new assignments

Decisions made by you will often impact the team in which they reside

Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture

Please note that this role may require you to work in rotational shifts