Fidelity Hiring Safety Writer — Executive

M.Pharm Safety Writer — Executive (Andheri East)

M.Pharm Safety Writer (Executive) vacancy at Fidelity, Andheri East. 1–2 yrs experience. Apply now.

Fidelity is hiring an Executive Safety Writer to join its pharmacovigilance team in Andheri (East). This role suits M.Pharm graduates with 1–2 years’ experience in safety literature, report writing and regulatory submissions for Europe, the UK and ROW markets. You will draft RMPs, PSURs/PBRERs and ACOs, manage literature searches, extract safety data from databases and coordinate reviews with Quality and Medical teams — work that directly supports patient safety and regulatory compliance.

Company Overview

Fidelity is a safety‑focused contract research and pharmacovigilance partner that delivers high‑quality safety writing, database management and regulatory support to global pharmaceutical clients. The company emphasises data integrity, timely delivery and regulatory compliance, working across Europe, the UK and diverse ROW markets. Fidelity’s safety writers contribute to public health by translating complex safety data into accurate, regulatory‑ready documents used in submissions and ongoing product monitoring.

Why join Fidelity

• Strong focus on pharmacovigilance and regulatory compliance.
• Collaborative environment connecting safety, medical and quality reviewers.
• Regular exposure to international guidelines (GVP, MHRA, ICH) and inspection readiness.

Job Role & Responsibilities

Executive Safety Writer — Key Deliverables

• Draft and compile core pharmacovigilance documents: RMPs, PSURs/PBRERs, Periodic Benefit‑Risk Evaluation Reports (PBRERs), and Annual Compliance Overviews (ACOs) for EU, UK and ROW markets (Ukraine, South Africa, Kazakhstan etc.).
• Generate Literature Lists (LL) and procure safety data from internal databases and cross‑functional stakeholders (sales, clinical studies, license updates).
• Perform systematic literature searches and screen retrieved articles for relevance and impact on benefit‑risk profiles.
• Compile and present safety data (RSI, study results, spontaneous reports) within timelines and according to client templates.
• Send drafts for Quality Review (QR) and manage responses to QR comments; coordinate with Medical Reviewers to resolve clinical queries and finalize documents.
• Support inspections and audits; contribute to SOP drafting and updates related to safety writing and report management.
• Respond to regulatory authority queries in collaboration with the safety and medical teams.

This role requires meticulous attention to data accuracy, strong medical writing skills and the ability to coordinate multiple reviewers while meeting strict regulatory timelines.

Eligibility / Qualifications

Minimum education:

• M.Pharm (preferably with specialization in Pharmacology, Pharmaceutics, or Pharmaceutical Analysis).

Experience required:

• 1–2 years in pharmacovigilance, safety writing, medical writing or regulatory affairs with hands‑on exposure to PSUR/PBRER and RMP preparation.

Technical skills & competencies:

• Good knowledge of PSUR, RMP, EMA GVP modules and MHRA guidance.
• Proficiency in literature search tools (PubMed, Embase), and familiarity with safety databases and signal detection concepts.
• Strong MS Office skills (Word, Excel, PowerPoint) for report preparation and data presentation.
• Excellent written and verbal English communication.

Preferred (Good to Have):

• Prior experience responding to regulatory queries.
• Exposure to eCTD structure or regulatory submission processes.
• Basic understanding of statistics applied to safety data (descriptive summaries).

Relevant courses (comma-separated): M.Pharm, B.Pharm, PG Diploma in Pharmacovigilance, Certificate in Medical Writing, MSc Pharmacology, PG Certification in Regulatory Affairs, Short course in Literature Searching and Systematic Reviews

Location & Salary

Location: Fidelity — Andheri (East), Mumbai (onsite)

Job Code: FHS/2025/INS/25

Compensation: Competitive and commensurate with experience. Fidelity offers a structured benefits package and opportunities for technical growth within pharmacovigilance and regulatory writing.

Application Process

Interested candidates should email their CV to: hrrecruitment@fidelityhs.com

Application tips:

• Use the job code FHS/2025/INS/25 in the subject line.
• Highlight your experience with PSUR/PBRER and RMP drafting in the first paragraph of your cover letter or email.
• Attach relevant training certificates (pharmacovigilance, medical writing) where available.

FAQs

Q: What is the minimum qualification for this role?
M.Pharm is required; candidates with a strong pharmacovigilance or medical writing background are preferred.

Q: How much experience is needed?
1–2 years of pharmacovigilance or safety writing experience is expected.

Q: Do I need prior experience with MHRA/EMA guidelines?
Yes. Familiarity with EMA GVP modules and MHRA guidance is strongly preferred.

Q: Is onsite presence mandatory?
Yes. This position is based onsite at Andheri (East).

Q: What documents should I include in my application?
An updated CV, brief cover note highlighting PSUR/RMP experience, and copies of relevant certificates.

Q: Will this role involve audits and inspections?
Yes. The writer must support audits and inspections and may assist in SOP preparation.

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+----------------------+---------------------------------------------------------+
| Company              | Fidelity Health Solutions (Pharmacovigilance)           |
+----------------------+---------------------------------------------------------+
| Vacancies            | Executive Safety Writer                                 |
+----------------------+---------------------------------------------------------+
| Required Education   | M.Pharm                                                  |
+----------------------+---------------------------------------------------------+
| Experience           | 1–2 years in pharmacovigilance / safety writing         |
+----------------------+---------------------------------------------------------+