About the job

Skill required: Pharmacovigilance – Pharmacovigilance and Drug Safety Surveillance

Designation: Associate

Job Location: Mumbai

Qualifications: Any Graduation

Years of Experience: 1-3 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.

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.

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 are required to solve routine problems, largely through precedent and referral to general guidelines

Your expected interactions are within your team and direct supervisor

You will be provided detailed to a moderate level of instruction on daily work tasks and detailed instruction on new assignments and the decisions that you make that would impact your work

You will need to be well versed with basic statistics and terms involved in the day to day business and use it while discussing with stakeholders

You will be required to help in the overall team’s workload by managing your deliverables and help the team when required

You will be an individual contributor as a part of a team, with a predetermined focused scope of work.

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

Any Graduation