Drug Safety Associate II

Organisation Description
EMD Serono, Inc. is a leader in US biotechnology, focusing on reproductive health, metabolic endocrinology, and neurology. More than 500 people work in the world-class facilities in Rockland, MA, and approximately 250 work in the field.
Description



The purpose of this role is to provide for the timely investigation, processing, submission and follow up of all adverse event reports on marketed products according to EMD Serono SOP's, FDA guidance's and local work instructions.

Specific duties include:

1. Master basic working knowledge of labeled information for all marketed products.

2. Receive, collect, and document accurate information on potential adverse event reports

submitted by all reporters including consumers, health professionals, co-manufacturers,

EMD Serono Call Centers, USMI, and other Serono staff.

3. Log onto USPS phone line to receive and process incoming calls of potential adverse event

reports.

4. Promptly submit documentation of calls / communication received to the Drug Safety Case

Initiator on the day received.

5. Collect accurate and complete investigative and follow up information on spontaneous

and solicited adverse event reports from consumers, health professionals, co-manufacturers, and

other EMD Serono staff (as directed by a Medical Safety Scientist) through telephone interview and

approved written Data Collection Forms.

6. Implement EMD Serono's SOP and local work instruction for collection of safety data under HIPAA.

7. Respond to queries from consumers and health professionals limited to discussing what is "on the

label" and referring callers to USMI for more specific queries according to local work instruction.

8. Documentation of all external contacts on the "Adverse Event Contact Form".

9. Prepare the narrative summary for adverse events according to FDA guidelines, EMD Serono SOPs /

narrative and local work instructions.

10. Process assigned cases in the validated database (ARISg) by performing assigned roles (data

entry, safety processing, and safety reporting) within Global and local timelines.

11. Code adverse events, medical history and suspect drugs in MedDRA and other company

dictionaries.

12. Conduct timely follow-up of adverse event reports to document outcome as directed by a

Medical Safety Scientist, EMD Serono SOPs, FDA guidelines and local work instructions.

13. Submit documentation of follow-up activities to the Medical Safety Scientist on the day received.

14. Prepare and adhere to USPS procedures, EMD Serono SOPs, and FDA guidelines for the submission

of all initial and follow-up serious labeled reports.

15. Participate in WWCS&P reporting obligations by completing all US serious adverse event

reports within the designated times to meet global reporting requirements.

16. Implement EMD Serono SOPs, and local work instructions for collecting information on specific safety

issues including lack of efficacy, in utero exposure and disease states identified for close

monitoring.

17. Collaborate with USPS team members in the development and review of written materials,

including data collection and tracking tools, work instructions, and SOPs.

18. Referral to USPS Director of all reports representing potential legal actions.

19. Implement local work instructions for call centers and patient support programs.

20. Contribute to the development of the USPS Team by participating in USPS training programs,

giving presentations on relevant topics and supporting departmental objectives.

21. Observe all USPS guidelines for documentation of adverse event reports.

22. Participate in Periodic Report preparation and adverse event reconciliations as requested.

23. Completion of other assigned projects


EDUCATION/LANGUAGES

Bachelors Degree in Pharmacy/ Nurse Practitioner/other health professional with life sciences

degree and 3 to 5 years experience in Drug Safety

Detailed knowledge of FDA and other regulatory authorities regulations.

English language.

PROFESSIONAL SKILLS & EXPERIENCE

Good organizational skills and ability to follow projects to completion

Experience with database applications, and excellent computer skills

PERSONAL SKILLS & COMPETENCIES

Ability to effectively communicate with consumers, and health professionals

Ability to work effectively as a member of a dynamic team.