Skill required: Pharmacovigilance - Medical Affairs
Designation: Team Lead/Consultant
Job Location: Bengaluru
Years of Experience: 7-11 years
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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 work well in a team
Roles and Responsibilities
- In this role, you need to analyze and solve moderately complex problems
- You are required to create new solutions, leveraging and, where needed, adapting existing methods and procedures
- You are required to understand the strategic direction set by senior management, clearly communicate team goals, deliverables, and keep the team updated on change
- Your primary upward interactions are with your direct supervisor
- You may interact with peers and/or management levels at a client and/or within Accenture
- You will be provided with guidance when determining methods and procedures on new assignments
- The decisions that are made by you will often impact your team
- You would be an individual contributor and/or oversee a small work effort and/or team.
Please note this role may require you to work in rotational shifts.
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