Crescent Pharma Hiring Pharmacovigilance Officer (Signal Detection) roles
- PV Officer (Signal Detection) – B.Pharm/M.Pharm, Thane
- Company Overview
- Job Role & Responsibilities
- Key responsibilities
- What success looks like
- Eligibility / Qualifications
- Minimum qualifications
- Desirable experience & skills
- Relevant courses (comma-separated)
- Location & Salary
- Application Process
- FAQs
- Who should apply for this role?
- Is experience with specific safety systems required?
- What are the core deliverables?
- Will there be cross-functional collaboration?
- What documents should I attach when applying?
- Summary Table
PV Officer (Signal Detection) – B.Pharm/M.Pharm, Thane
B.Pharm/M.Pharm candidates with 5+ years sought for Pharmacovigilance Officer (Signal Detection) roles in Thane. Apply via email.
Crescent Pharma is hiring experienced pharmacovigilance professionals to join its safety team in Thane. If you have hands-on expertise in signal detection, aggregate safety reporting, and regulatory-compliant safety surveillance, this role gives you ownership of critical PV activities that protect patient safety and support global product stewardship.
Company Overview
Crescent Pharma operates in the pharmaceutical services space, supporting product safety and regulatory compliance across marketed portfolios. The company focuses on practical, compliance-driven pharmacovigilance operations and works with pharmaceutical teams to maintain high standards for drug safety monitoring. Joining Crescent means contributing directly to patient safety and regulatory readiness within a compact, process-oriented PV team.
Job Role & Responsibilities
The Pharmacovigilance Officer / Executive (Signal Detection) will be the subject-matter point of contact for signal identification, aggregate reporting, and periodic safety assessment. This is an office-based role in Thane that requires close collaboration with safety physicians, regulatory affairs, and global safety partners.
Key responsibilities
- Lead signal detection activities across marketed products, using statistical and qualitative review techniques.
- Prepare and author aggregate safety reports: PSURs (Periodic Safety Update Reports), PADERs, PBRERs (Periodic Benefit-Risk Evaluation Reports), and Safety Update Reports.
- Contribute to Risk Management Plans (RMPs) and support updates based on emerging safety data.
- Conduct literature screening, safety surveillance, and line listings review to detect emerging signals.
- Perform quantitative analyses (disproportionality, trend analysis) and interpret results to support signal assessment.
- Coordinate with Medical Affairs, Regulatory Affairs, and PV physicians for causality assessment and safety communications.
- Maintain documentation for signal management and escalate safety concerns per SOPs and timelines.
- Ensure compliance with global regulatory requirements (ICH, EMA, FDA) and local regulations for safety reporting.
- Support aggregate report submission timelines and interact with external vendors or partners when required.
- Participate in audits and inspections; support responses and corrective actions related to signal detection and reporting.
What success looks like
- Timely identification and thorough assessment of safety signals.
- High-quality, inspection-ready aggregate reports and RMP inputs.
- Clear, evidence-based communication with cross-functional stakeholders.
Eligibility / Qualifications
Minimum qualifications
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or Medical Sciences (B.Pharm, M.Pharm preferred).
- 5+ years of total experience in pharmacovigilance with demonstrable experience in signal detection and aggregate report authoring.
Desirable experience & skills
- Proven experience authoring PSURs, PBRERs, PADERs, RMPs, and safety update reports.
- Strong understanding of MedDRA coding, ICH guidelines, and global safety regulations.
- Experience with safety databases (Argus, ArisGlobal, VigiBase, Oracle Argus) and signal detection tools.
- Competence in literature review, data mining, and basic statistical methods for signal detection.
- Excellent scientific writing, critical thinking, and stakeholder management skills.
- Ability to work under deadlines and manage multiple safety projects concurrently.
Relevant courses (comma-separated)
B.Pharm, M.Pharm, Pharm.D, B.Sc Life Sciences, M.Sc Pharmacology, Clinical Research, Pharmacovigilance Certification, Postgraduate Diploma in Pharmacovigilance, Regulatory Affairs.
Location & Salary
- Location: Thane, Maharashtra (Work from Office)
- Work Model: On-site (office-based)
- Compensation: Competitive, commensurate with experience and PV expertise. Exact salary will be discussed during selection.
Application Process
Interested candidates should submit their CVs and a short cover note highlighting signal-detection and aggregate-reporting experience to: asharma@crescentpharma.com
In your email subject line, mention: “PV Officer – Signal Detection | Your Name | 5+ yrs”
Shortlisted candidates will be contacted for an initial screening followed by a technical interview and HR discussion. Please attach certificates and a brief summary of PSUR/PBRER contributions if available.
FAQs
Who should apply for this role?
Candidates with a pharmacy or life-sciences background and at least 5 years’ hands-on experience in pharmacovigilance signal detection and aggregate report authoring.
Is experience with specific safety systems required?
Familiarity with PV databases such as Argus or ArisGlobal is highly desirable. Candidates with strong signal detection experience on any validated safety database will be considered.
What are the core deliverables?
Timely safety signal assessments, high-quality PSURs/PBRERs/PADERs, RMP inputs, and compliance-ready documentation.
Will there be cross-functional collaboration?
Yes. You will work closely with Medical Affairs, Regulatory Affairs, Quality, and external vendors when required.
What documents should I attach when applying?
Updated CV, experience certificates, and any examples or summaries of prior PSUR/PBRER contributions (redacted if confidential).
This role is a focused opportunity to advance your PV career in signal detection and aggregate reporting. If you’re driven by data, committed to patient safety, and skilled at turning safety data into clear regulatory action, Crescent Pharma’s Thane office could be the right next step.
Summary Table
| Category | Details |
|---|---|
| Company | Crescent Pharma, Thane |
| Vacancies | Pharmacovigilance Officer / Executive (Signal Detection) |
| Required Education | B.Pharm, M.Pharm, Pharm.D, B.Sc Life Sciences, M.Sc Pharmacology, Pharmacovigilance Certification |
| Experience | 5+ years in pharmacovigilance with signal detection & aggregate report authoring |
To apply for this job email your details to asharma@crescentpharma.com
