Pharmacovigilance Lead Author Jobs

Written by

in

APCER Life Sciences Lead Author Jobs in Noida and Ahmedabad: 6+ Years of Experience Required

APCER Life Sciences are looking for an experienced professional to join as Lead Author – Aggregate Reports in Noida and Ahmedabad. The person we are seeking will have at least 6 years’ experience and will be an expert in the authoring of pharmacovigilance aggregate reports (PBRER, PSUR, DSUR, PADER and RMPs).

The successful candidate will be involved in the preparation of aggregate reports and more generally in pharmacovigilance activities, with a particular emphasis on the preparation of key drug safety documents. This is a role for an experienced pharmacovigilance professional with a proven history of scientific writing and in the preparation of aggregate reports.

APCER Life Sciences Recruitment 2026: Job Details

Particulars Details
Company APCER Life Sciences
Position Lead Author – Aggregate Reports
Department Pharmacovigilance
Job Locations Noida / Ahmedabad
Experience 6+ years
Key Expertise PBRER, PSUR, DSUR, PADER and RMP authoring
Application Mode Email

About APCER Life Sciences

APCER Life Sciences provides a range of services within the life sciences and pharmaceutical sector, with a particular focus on pharmacovigilance. They offer support with drug safety activities and the associated regulatory requirements for both pharma and healthcare organisations.

This is a recruitment for an experienced Lead Author to be involved in the preparation and management of PV aggregate reports.

Lead Author – Aggregate Reports: Key Responsibilities

The role is around writing pharmacovigilance aggregate reports and the associated drug safety documentation.

Key areas of expertise required include:

  • PBRER authoring: the preparation of Periodic Benefit-Risk Evaluation Reports (PBRERs) to present an overall evaluation of the benefit-risk profile of a medicinal product.
  • PSUR Authoring: Development of Periodic Safety Update Reports (PSURs) covering post-marketing safety information.
  • DSUR authoring: preparation of Development Safety Update Reports (DSURs) for investigational products during the course of clinical development.
  • PADER Authoring: Preparation of Periodic Adverse Drug Experience Reports (PADERs) for drug safety reporting.
  • RMP Authoring: Development of Risk Management Plans (RMPs) addressing identified and potential safety concerns and risk minimisation activities.
  • Aggregate report management: provide support for pharmacovigilance reporting activities via accurate scientific documentation and report preparation.

Eligibility Criteria for APCER Life Sciences Lead Author Jobs

Experience Requirements

Candidates should have:

  • At least 6 years’ relevant professional experience.
  • Expertise in the authoring of pharmacovigilance aggregate reports.
  • Experience with PBRER and PSUR preparation.
  • Knowledge of DSUR and PADER authoring.
  • Expertise in the preparation of Risk Management Plans (RMPS).

Required Technical Expertise

Applicants should have strong knowledge of the following pharmacovigilance documents:

Report / Document Full Form
PBRER Periodic Benefit-Risk Evaluation Report
PSUR Periodic Safety Update Report
DSUR Development Safety Update Report
PADER Periodic Adverse Drug Experience Report
RMP Risk Management Plan

Candidates with a good deal of experience in producing these documents should be considering applying for this senior level post.

Job Location

APCER Life Sciences is hiring for the Lead Author – Aggregate Reports position at the following locations:

  • Noida, Uttar Pradesh
  • Ahmedabad, Gujarat

Candidates can apply to the site that best fits their availability and preference.

How to Apply for APCER Life Sciences Lead Author Recruitment 2026

Any suitable and eligible candidates with 6+ years’ relevant aggregate report authoring experience are of course encouraged to send over their most up to date CVS directly to the recruitment team.

Email: talentacquisition@apcerls.com

Application Subject: Application for Lead Author – Aggregate. Candidates should ensure their CVS highlight their experience in PBRER, PSUR, DSUR, PADER and RMP authoring. authoring.

APCER Life Sciences Lead Author Recruitment 2026: Summary

Recruitment Details Information
Company APCER Life Sciences
Position Lead Author – Aggregate Reports
Department Pharmacovigilance
Experience 6+ years
Required Expertise PBRER, PSUR, DSUR, PADER and RMP authoring
Locations Noida / Ahmedabad
Application Mode Email
Email Address

Frequently Asked Questions

1. What position is available at APCER Life Sciences?

APCER Life Sciences are recruiting for the role of Lead Author – Aggregate Reports.

2. How much experience is required?

Candidates should have a minimum of 6 years’ experience.

3. What pharmacovigilance reports should the candidate have experience in authoring?

Candidates should be experienced in PBRER, PSUR, DSUR, PADER and Risk Management Plan (RMP) authoring.

4. What are the job locations?

The openings are available in Noida and Ahmedabad.

5. How can candidates apply for APCER Life Sciences Lead Author jobs?

Interested candidates should send their updated CVS to talentacquisition@apcerls.com