Proj Mgr Drug Safety

Job Number


Level of education required (or experience level which may be substituted for level of education).
Professional designations/certifications/licenses required
- Non-degree + 6-7 yrs safety experience*
- Associate degree + 5-6 yrs safety experience*
- Associate degree RN + 5-6 yrs safety experience*
- BS/BA + 4-5 yrs safety experience*
- MS/MA + 3-4 yrs relevant experience** (2-3 yrs safety experience)
- PharmD + 2-3 yrs relevant experience** (1-2 yrs safety experience)
For PharmD, a one-year residency of fellowship can be considered relevant experience.
Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.
*Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
**Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.
EudraVigilance Certification preferred


- Compliance with client and global regulatory requirements
- Good knowledge of the relevant worldwide pharmacovigilance regulations and guidelines.
- Good knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
- Good knowledge of ICH guidelines.
- Good knowledge of medical and drug terminology
- Work collaboratively with PSS Management’s team
- Good verbal, written and presentation skills.
- Good communication.
- Leadership capabilities
- Anticipate/identify problems and takes appropriate action to correct.
- Knowledge of Medical Device Reporting desirable
- Knowledge of aggregate reporting
- Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.
- Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
- Financially intuitive


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