Job title: Team Lead/Consultant-Pharmacovigilance
Job description: Job Description
Skill required: Pharmacovigilance – Pharmacovigilance and Drug Safety Surveillance
Designation: Team Lead/Consultant
Job Location: Mumbai
Qualifications: Any Graduation
Years of Experience: 7-11 years
About Accenture Operations
Accenture is a global professional services company with leading capabilities in digital, cloud and security. Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Interactive, Technology and Operations services – all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 674,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at
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
As a team lead you will be expected to:
- Understand and effectively manage the team’s governance and performance
- Understand the level of risk & propose mitigation plans and partner with other support teams to resolve requests/issues in a timely manner
- Clearly communicate team goals and deliverables and keep the team updated on changes
- Coach team members and provide the first level advice on procedures/methods
- Solve increasingly complex problems & effectively delegate to develop and groom team members for succession planning
- Maintain client relationships interface through regular connects and emails
- Understand client priorities and problems & help translate actions for the team
- Use innovation to identify opportunities to optimize processes, decrease costs and increase client value
- Use data analytics and story-telling techniques to enhance the client journey
Please note this role may require you to work in rotational shifts.
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Location: Mumbai, Maharashtra
Job date: Sat, 26 Feb 2022 23:18:51 GMT
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