Health Clinical Services Specialist - Pharmacovigilance

Skill required: Pharmacovigilance Services - Customer Acquisition Strategy & Implementation

Designation: Deputy General Manager Pharmacovigilance Services

Qualifications:Bachelor of Pharmacy

Years of Experience:5 to 8 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.

Support in the context of public disclosure of clinical documents in accordance with client and Regulatory requirements as communicated by the client.

Clinical documents should be redacted to protect the privacy of individuals, groups, and staff associated with a clinical study so that these documents can be made available for public, post approval from EU and US regulatory authorities.

Privacy data should be removed or redacted from the clinical documents before public disclosure per the Redaction Checklist.

Quality review of redacted clinical documents per specific guidelines.

Finalization of the fully redacted documents

Ensure to complete the task including redaction and incorporation of QC comments in clinical documents within the agreed timelines.

Must be well versed with EU Policy 70 and Health Canada guidelines on clinical trial data transparency.

Should have thorough knowledge of redaction and anonymization techniques.

Well versed in preparation of anonymization report and justification tables.What are we looking for?

Ability to establish strong client relationship

Ability to manage multiple stakeholders

Ability to meet deadlines

Ability to perform under pressure 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