APCER Life Sciences is inviting applications for the position of Pharmacovigilance Aggregate Report Manager in Canada. This opportunity is suitable for experienced pharmacovigilance professionals with a strong background in aggregate safety reporting and drug safety management.

Candidates with 3–6 years of experience in aggregate reporting who are currently based in Canada are eligible to apply.

Job Details

• Company Name: APCER Life Sciences
• Job Title: Pharmacovigilance Aggregate Report Manager
• Department: Pharmacovigilance / Drug Safety
• Job Location: Canada
• Required Experience: 3–6 years
• Eligible Candidates: Candidates currently based in Canada only
• Application Email: talentacquisition@apcerls.com

About APCER Life Sciences

APCER Life Sciences is a life sciences services company that supports pharmaceutical and biotechnology organizations with pharmacovigilance, regulatory affairs, clinical research, and drug safety services.

The company focuses on supporting clients in meeting regulatory requirements and maintaining high standards of patient safety throughout the medicine lifecycle.

Job Responsibilities

The selected candidate will be expected to support aggregate safety reporting activities and help ensure the quality and accuracy of pharmacovigilance reports.

Key responsibilities may include:

• Preparing and reviewing aggregate safety reports, including Periodic Safety Update Reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs).
• Coordinating safety data collection and reconciliation for periodic reports.
• Reviewing adverse drug reaction data and identifying relevant safety trends.
• Ensuring reports meet applicable regulatory requirements and submission timelines.
• Collaborating with pharmacovigilance, regulatory affairs, clinical, and medical writing teams.
• Maintaining report documentation and supporting quality review processes.
• Ensuring consistency, accuracy, and completeness of safety information.

Note: These responsibilities are typical of an aggregate reporting management role; the employer’s exact responsibilities should be confirmed during recruitment.

Eligibility Criteria

Candidates interested in this position should meet the following requirements:

• 3–6 years of professional experience in aggregate reporting.
• Relevant experience in pharmacovigilance or drug safety.
• A background in preparing or reviewing periodic safety reports.
• Knowledge of applicable pharmacovigilance regulations and reporting guidelines.
• Strong analytical, documentation, communication, and coordination skills.
• Current residence in Canada, as specified in the recruitment announcement.

A degree in pharmacy, life sciences, medicine, or a related discipline may be relevant to this role, subject to the employer’s specific requirements.

Salary and Benefits

The recruitment announcement does not specify the salary, benefits, employment type, or work arrangement. Candidates should confirm these details with APCER Life Sciences during the application process.

How to Apply

Interested and eligible candidates can apply by sending their updated CV to the following email address:

Email: talentacquisition@apcerls.com

Applicants should highlight their experience in aggregate reporting, PSUR/PBRER preparation, pharmacovigilance compliance, and safety report review in their CV.

Important: Only candidates currently based in Canada are eligible according to the posted announcement. Applicants should verify the vacancy and any additional requirements before sharing personal information.

Frequently Asked Questions (FAQs)

1. What is the role of an Aggregate Report Manager in pharmacovigilance?

An Aggregate Report Manager oversees the preparation, review, and coordination of periodic drug safety reports. The role helps ensure that cumulative safety data are accurately evaluated and reported according to applicable regulatory requirements.

2. What are PSURs and PBRERs?

A Periodic Safety Update Report (PSUR) and a Periodic Benefit-Risk Evaluation Report (PBRER) are periodic reports that evaluate a medicine’s safety information and benefit-risk balance using accumulated data. PBRERs follow the ICH E2C(R2) framework.

3. What technical knowledge is required for aggregate reporting?

Relevant knowledge includes pharmacovigilance regulations, ICH guidelines, adverse event data analysis, signal detection concepts, safety database reconciliation, and preparation of periodic safety reports.

4. How much experience is required for this APCER Life Sciences vacancy?

The announcement specifies 3–6 years of experience in aggregate reporting. Candidates should demonstrate relevant practical experience in preparing, reviewing, or coordinating aggregate safety reports.

5. Can candidates living outside Canada apply?

According to the recruitment announcement, only candidates currently based in Canada are eligible. Candidates living outside Canada should not assume that relocation or remote work will be accepted unless the employer confirms otherwise.

Conclusion

The Pharmacovigilance Aggregate Report Manager position at APCER Life Sciences offers an opportunity for experienced drug safety professionals to pursue a role in aggregate safety reporting in Canada. Eligible candidates with 3–6 years of relevant experience can submit their CV to talentacquisition@apcerls.com for consideration.