Pharma Leaf Pharmacovigilance Job openings; RA & PV Specialist

  • Full Time
  • India

Pharmaleaf India Pvt Ltd

Pharmaleaf India Pvt Ltd

(a global regulatory organization, headquartered at Bangalore, India) is looking for a: Dynamic and efficient “RA & PV Specialist” proficient in: Pharmacovigilance

Key attributes: Ability to prioritize, adhere to time-lines, problem solving capabilities, strong team and liaising skills

Qualifications: Bachelor’s degree in life sciences or related field (Clinical, M Pharma (Pharmacology, PharmD, BAMS/BDS)

Industry experience: 3-5 years experience in Pharmacovigilance; Preferably from pharma establishment/company (Not CRO);

Market: India

Job Profile:

Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team members.

Responsibilities:

1. To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming:

2. To support Regulatory strategy for the execution of PV activities.

3. To assess & analyze timely processing of new and follow up reports of adverse effects & side-effects as well as SAE & Suspected and Unexpected Serious Adverse event Reaction (SUSARS))

4. Communication & Co-ordination with the Vendors, regulatory agencies & health care professionals.

5. To coordinate with cross functional teams to ensure PV compliance as per PvPi guidelines for marketed products.

6. To maintain PV data/databases.

7. To collect ADR report and submit to CDSCO, India and also to check for the precedence of the similar ADRs.

8. Well versed in literature search & extend PV support safety of the product.

9. Knowledge of PVPi module to prepare internal SOPS 10. Knowledge in RMP (Product risk management plan)

11. Knowledge in preparation of audit report

12. Publishing of the dossier in hardcopy and softcopy for the submission at the agency. To submit the PSUR, DSUR, bi annual status reports to CDSCO

13. Quality Control of the documents/dossier before dispatch or final submission on the Portal

14. Communication and Co-ordination with the Agency (Assistant Drug Controller/Drug Inspector CDSCO, SLA, IPC, FSSAI)

Location: Mumbai

Attractive package and multinational exposure

If you think you are a fit or match reach out to us on: Email: cv@pharmaleaf.com 

Pharma Leaf Pharmacovigilance Job openings; RA & PV Specialist
Pharma Leaf Pharmacovigilance Job openings; RA & PV Specialist

To apply for this job email your details to cv@pharmaleaf.com

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