Skill required: Pharmacovigilance – Medical Affairs
Designation: Management Level – New Associate
Job Location: Chennai
Years of Experience: 0 to 1 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, reviewingÂ 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?
• Ability to establish strong client relationship
• Adaptable and flexible
• Agility for quick learning
• Detail orientation
• Problem-solving skills
Roles and Responsibilities
• In this role you are required to solve routine problems, largely through precedent and referral to general guidelines
• Your primary interaction is within your own team and your direct supervisor
• In this role you will be given detailed instructions on all tasks
• The decisions that you make impact your own work and are closely supervised
• You will be an individual contributor as a part of a team with a predetermined, narrow scope of work
• Please note that this role may require you to work in rotational shifts